ML20217H745

Informs That Mallinckrodt Registries NR-0440-D-101-U, NR-0440-D-103-U & NR-0440-D-104-U Removed from Registry Sys. Certificates for Products Not Considered to Be Sources or Devices

ML20217H745
Person / Time
Issue date:	05/23/1995
From:	NRC
To:	NRC
References
SSD, NUDOCS 9804060043
Download: ML20217H745 (2)

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NOTE T0: Files NR-0440-D-101-0, NR-0440-D-103-0, NR-0440-D-104-U

-Mallinckrodt Registries NR-0440-D-101-0, NR-0440-D-103-U,'and NR-0440-0-104-0 were removed from the registry system.

These registration certificates are for products that are not considered to be sources or devices.

The.

certificates were originally AEC catalogue sheets that were inadvertently.

. turned 'into registration certificates. The information in these files is for information purposes only.

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September ?' 1992 u :,n.,nc 44 ua.

o Mr. S. Baggett Division of Industrial and Medical Nuclear Safety NMSS U.S. Nuclear "egulatory Commission Washington, D.C. 20555 i

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Dear Mr. Baggett:

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J The enclosed documentation is provided to support Mallinckrodt Medical's request that Y

certain NRC license files be made inactive. The licenses in questions are NR440D101U, NR440D103U and NR440D104U (Technetium-99m Generators), and MO-440-S-105S

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(Xenon dispensing device). The supporting information shows that none of the generators

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have been produced in over 10 years, and the xenon dispensing device has not been produced i

in over 7 years.

We feel this information is sufficient to have these license files made inactive. If you have any questions, or require additional information, please contact me at (314) 344-3926. Thank j

you for your consideration.

Sincerely yours,

(( icj sdClA y tog Kathryn A. James v

Enclosures cc: Ms. Glenda Jackson - NRC l

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No.: NR440D101U Device Type: Technetium-99m Pertechnetate Generator Model: 5540,5541,5542 Description of Product The Technetium-99m generator consists of a bottle of cluant, which is normal saline, and an ion exchange column onto which Molybdenum-99, a radioactive element which decays to Technetium-99m, is irreversibly bound. The radioactive column is enclosed in lead shielding and the entire setup is contained in a plastic outer shell. To obtain Technetium-99m from the column, an evacuated vial is placed below a plunger located in front of the generator and the plunger is depressed and turned. This opens a valve which allows a predetermined amount of cluant to flow through the Molybdenum-99 column. Technetium-99m, the decay product, is not bound to the column and is " washed" off with the saline into the evacuated vial. The Technetium-99m can then be used with radiopharmaceutical " cold kits" to perform a variety of diagnostic tests.

These early generators were round canisters in blue plastic outer shells. Neutron Molybdenum-99 was used in these generators.

Last time oroduct was used September 1971 Is any product still in the field?

Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns. The half life of Molybdenum 99 is 2.75 days, and the half F

life of Technetium-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. One year of decay for Mo-99 is about 133 half lives.

CSince September 1971 when the last generators were produced, over 2.793 half lives of Molybdenum-99 would have elapsed. This would effectively eliminate any radioactivity originally present in the generator.}

Documentation sourts Interviews with production line supervisors.

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l No.: : NR440D103U Device Type: Technetium-99m Pertechnetate Generator Model: Ultra-Technekow Models 006 through 012 '

Description of Product

.De Technetium-99m generator consists of a bottle of cluant, which is normal saline, and an ion exchange column onto which Molybdenum-99, a radioactive element which decays to -

Technetium-99m, is irreversibly bound. The radioactive column is enclosed in lead shielding and the entire setup _ is contained in a plastic outer shell. To obtain Technetium-99m from the column, an evacuated vial is placed below a plunger located in front of the generator and the

.q plunger is depressed and turned. This opens a valve which allows a predetermined amount

.of cluant to flow through the Molybdenum-99 column. ~ Technetium-99m, the decay product, is not bound to the column and is " washed" off with the saline into the evacuated vial. The Technetium-99m can then be used with radiopharmaceutical " cold kits" to perform a variety of diagnostic tests.

The Ultra-Technekow models 006 through 012 were rectangular, approximately 14 inches wide, with a blue plastic outer shell.

Imt time product was used January 1979 Is any product still in the field?

Although there may be physical pieces of these g:ncrators in the field, there is no radioactivity left in the columns. The half life of Molybdenum 99 is 2.75 days, and the half life of Technetium-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />. One year of decay for Mo-99 is about 133 half lives.

Since January 1979 when the last generator was produced, over 1,825 half lives of Molybdenum-99 would have elapsed. This would effectively eliminate any radioactivity

. originally present in the' generator.

Documentation source The last Ultra-Technekow generator was produced on January 5,1979. His date was obtained by examining the final generator itself, which has the date of manufacture written on the front.

No.: NR440D104U Device Type: Technetium-99m Pertechnetate Generator Model: Elutek 6724

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Descriotion of Product The Technetium-99m generator consists of a bottle of cluant, which is normal saline, and an ion exchange column onto which Molybdenum-99, a radioactive element which decays to Technetium-99m, is irreversibly bound. The radioactive column is enclosed in lead shielding and the entire setup is contained in a plastic outer shell. To obtain Technetium-99m from the column, an evacuated vial is placed below a plunger located in front of the generator and the f

plunger is depressed and turned. This opens a valve which allows a predetermined amount of cluant to flow through the Molybdenum-99 column. Technetium-99m, the decay product, is not bound to the column and is " washed" off with the saline into the evacuated vial. The i l i

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-Technetium-99m ca then be used with radiopharmaceut ca " cold k ts" to per orm a var ety of diagnostic tests.

The Elutek 6724 was manufactured for Abbott Laboratories in North Chicago, Illinois.

These generators were in bright orange plastic shells and were approximately 14 inches high, 9 inches wide and 6 inches deep.

Last time oroduct was used 1976 Is any oroduct still in the field?

Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns. The half life of Molybdenum 99 is 2.75 days, and the half life of Technetium-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />.95ince approximately 1976, when the last product was

' sold, over 2,128 half lives of Molybdenum-99 would have elapsed, effectively eliminating

. any radioactivity originally present in the generator.]

Documentation source Interviews with production line supervisors.

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No.:

MO44U-S-l05-S Scaled Source Type:

Xenon Dispensing Device Model: None Description of Product This license is in reference to a Xenon dispensing device, not a sealed source or Xenon source. This device was used for dispensing radioactive Xenon-133 gas used in ventilation lung imaging. The device, initially called a Xenomatic and later called a Xenomatic II, was-used to transfer the radioactive Xenon-133 gas from a vial into a delivery system. The Xenomatic II has now been replaced with the Xenotron I.

12st time oroduct was used September 1)85 Is any product still in the field?

Although there may be physical pieces of these Xenon dispensing devices in the field, they were not radioactive to begin with therefore the issue of residual activity is not applicable.

Documentation source The first Xenotron I was produced in September 1985. The last Xenomatic II was therefore produced and sold just prior to that, also in September 1985.

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PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNo request AND a copy of aH related letters /apphcations and drawings to: The Sealed Source Safety Secten, ATTN: CNef, OWFN Meu Stop 6 H3. Change the Ucense Tracidng System rnilestone to 19 and assign to reh code L5.

NOTE: Retain a copy of tNo request with the appHcaten and back0round files.

REQUESTER REGION / LOCATION:

/?)A /// /16, Dad h l

ll C 111 D IV DV D HQ D LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)

APeucANr8 NAME SOURCE REVIEW AMENDMENT OF REGISTRATION SHEET g,,

dhU.

MAL CONrROL NUMBER (S)

DEVICE REVIEW LETTERIAPPUCATON DATE UCENSE NUMBER (S)

CUSTOM REVIEW S~/Of~3 g y,.

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e2 QO 3 l/17fK f/Alc'.

PM2fldsd /h Jhr'b /MO Go y5 FOR SSSS USE ONLY REVIEWER MODEL NUMaEMS NUteER ASSIONED f/kdibuU N ~O oATE REcEmn oATE A38GNED DATE TO FEES

/ '

TYPE OF ACTION (Indicate the namnber of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C)

DEVICE (9A)

SOURCE (90)

DEVICE (98)

NEW NEW NEW NEW AMENDMENT MMENOMENT

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AMENDMENT AMENDMENT jfl0 SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Spec #y)

TOTAL NUMBER OF NOTES g g/ ~ff)Ad.b C REVIEW HOURS gj/

t NUMBER OF N

DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR BILLING PURPOSES Oft.Y j NEW REGISTRATION -

_j PRODUCT INACTIVE -

NAME CHANGE ADDRESS CHANGE ADD TO BILUNG REMOVE FROM BILUNG FOR FEE USE ONLY TYPEOFPEE FEE CATEGORY

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9C R 90 l 9A 98 AMOUNT RECEIVED CHEM NUMBER MATANN UPDATED AS REQUIRED j MATSYS UPDATED DATE OF CHEM loo AS REQUIRED APenoveD SV DATE RETURN DATE COMMENTa totCFORM9e7 lH 4

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