ML20217H611
| ML20217H611 | |
| Person / Time | |
|---|---|
| Issue date: | 03/20/1998 |
| From: | Steven Baggett, John Lubinski NRC |
| To: | |
| Shared Package | |
| ML20217H609 | List: |
| References | |
| SSD, NUDOCS 9804030410 | |
| Download: ML20217H611 (4) | |
Text
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REGISTRY OF: RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE H b NR-440-D-807-S DATE:
MAR 2 01993 PAGE 1 OF 4
~ DEVICE TYPE:
Technetium-99m Pertechnetate Generator MQDEL1-Elutek 6724 DISTRIBUTOR:
Abbott Laboratories Abbott Park North Chicago, IL 60064 f
l MMJUFACTURER :
Mallinckrodt' Medical, Inc.
2703 Wagner Place Maryland Height, MO 6304?.
SEALED SOURCE MODEL DESIGNATIONt Not Applicable ISOTOPE:
MAKIMUM ACTIVITY:
Molybdenum-99 1,080 mci (40 GBq)
LEAK TEST FREOUENCY:
Not Required PRINCIPAL USE:
(V) General Medical Use CUSTOM DEVICE:
YES X
NO 9004030410 980320 PDR RC SSD PDR q
f REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES
(
SAFETY EVALUATION OF DEVICE i
NO.. NR-440-D-807-S DATE:
MAR 2 01998 EAgg. 2 OF 4 L
DEVICE TYPE:
Technetium-99m Pertechnetate Generator I
l RESCRIPTION:
1 The Abbott Elutek Mo-99/Tc-99m generators, containing parent Mo-99 prepared from irradiated stable molybdenum, are identical f
to the Mallinckrodt Ultra Technekow generators, Model Nos. 006-010.
Only labeling and packaging changes are involved.
The Abbott product is labeled " Manufactured for Abbott," caries a j
different trade name, and employs color scheme changes in I
labeling and packaging.
The generators are produced, labeled, and packaged by Mallinckrodt and shipped to Abbott for
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distribution.
The product is included in the FDA approved New Drug Application No. NDA 17-243 for Mallinckrodt Chemical Works (now Mallinckrodt Medical).
The Tc-99m generator consists of a bottle of eluant, which is normal saline, and an ion exchange column onto which Mo-99, a radioactive element which decays to Tc-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 Tc-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 eluant to flow through the Mo-99 column.
Tc-99m, the decay product, is not bound to the column and is
" washed" off the saline into the evacuated vial.
The Tc-99m can then be used with radiopharmaceutical " cold kits" to perform a variety of diagnostic tests.
l The Elutek 6724 was manufactured for Abbott Laboratories in North Chicago, Illinois.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES l
SAFETY EVALUATION OF DEVICE I
I i
l NO.: NR-440-D-807-S DATE:
NMR 2 01998 PAGE 3 OF 4 DEVICE TYPE:
Technetium-99m Pertechnetate Generator LIMITATIONS AND/OR OTHER CONSIDERATIOt{S OF USE:
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= The devices may be used by persons specifically licensed by
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the NRC or an Agreement State.
Handling, storage, use, transfer and disposal are to be detennined by the licensing authority.
Leak test for this device is not required.
This registration sheet and the information contained within the references shall not be changed without the written consent of the NRC.
SAFETY ANALYSIS
SUMMARY
j The Model Elutek 6724 is not a current product manufactured by Mallinckrodt Medical Inc.
Although there may be physical pieces of these generators in the field, there is no radioactivity left in the columns.
The half life of Mo 'J9 is 2.75 days, and the half life of Tc-99m is 6.02 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />.
Since September 1976 when the last generators were produced, enough half lives have elapsed to effectively eliminate any radioactivity originally present in the generator.
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REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES SAFETY EVALUATION OF DEVICE j
i l
NCL2 NR-4 4 0- D-8 0 7 - S DATE1 MAR 2 01998 PAGE 4 OF 4 i
DEVICE TYPE:
Technetium-99m Pertechnetate Generator I
REFERENCES:
The following supporting documents for the Model Elutek 6724 generators are hereby incorporated by reference and are made a part of this registry document.
Mallinckrodt letter of September 24, 1992, requesting that this registry be made inactive.
1 NRC Registry NR-440-D-104-U dated April 2, 1974, describing thes devices.
ISSUING AGENCY I
U.S.
Nuclear Regulatory Commission MAR 2 01998 Date:
Reviewer:
-[ / '
/ John Wy Lubinski
[g22 MAR 2 01998 y
Date:
Concurrence:
/<
Steven L.
Baggett l
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