ML20128M319

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Amended Attachment Four to 940627 Registry of Radioactive Sealed Sources & Devices Safety Evaluation Device for Models S-11,S-16,S-18 & S-20.Certificate:NR-109-D-122-B
ML20128M319
Person / Time
Issue date: 09/13/1996
From:
NRC (Affiliation Not Assigned)
To:
References
SSD, NUDOCS 9610160060
Download: ML20128M319 (2)


Text

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(

l REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES  !

)

', SAFETY-EVALUATION OF DEVICE '

i (AMENDED ATTACIDEENT 9/13/96)  !

r i

) NO.: NR-109-D-122-B DATE: June 27, 1994 ATTACHMENT 4.

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- ABB SOURCE MODELS ,

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l ABB Maximum ANSI Amersham Model Activity 1 N542-1997 Model ,

Number Isotope (mci) Classification Number I i

S-11 Krypton-85 1,000 77C33232 KACK3349 l
77C33232 KACK4778 .

77C33332 KACQ4474 i NER-5842 '

NER-5872 i

S-16 Americum-241 5,000 77C56545 AMCQ6477 77C66645 AMCQ6785 [

3 77C66645 AMCK4754' i

'1 i l S-18 Strontium-90 70 77C65543 SIFQ2820  !

77C65543 SIFV328 >

77C65543 SIFQ6494 77C65543 SIFQ8213 i

, 77C65544 SIFW517 l SIFW518 I

S-20 Promethium-247 1,000 77C44342 PHCK2026 1

1

)

1

) This is the maximum activity for use in the device covered by this 4

registration certificate.

5 j 2 This source is manufactured by Du Pont Merck Pharmaceuticals, not  ;

Amersham.  !

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9610160060 960913 PDR RC *

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l PAGE1 ,

NRC FORM 567 U. lt. NUCLEAR RE1ULATORY COMMISSION 1 REQUEST FOR A SEALED SOURCE OR . ,

(DEVICE EVALUATION l INSTRUCTIONS: Sond this request AND a copy of all re% ' letters /applicates and drawings to: The Sealed Source Safety Section, ATTN: Chief, OWFN Mail Stop 6 H3. Change the Ucense Tracidng Systwn milestone to 19 and assign to reviewer code I-5.

NOTE: Retain a copy of this request with the applicatm and background files.

REQUESTER REGION / LOCATION.

]l R 11 ll1 IV UV R HQ U LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)

N NAME SOURCE REVIEW

' hENDMENT OF REGISTRATION SHEET mat CONTROL NUMBER (S) DEVICE REVIEW MBER S LETTER /APPUCATION DATE UCENSE NUMBER (S) CUSTOM REVIEW M '

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FOR SSSS USE ONLY n h * "

DATE RECENED 4/ w l96 DATE ASSK)NED Wd%

DATE TO FEES

( TYPE OF ACTION (Indicate the number of each type) als

'[

)(l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)

SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (98)

NEW NEW NEW NEW AMENDMENT AMENDMENT _

AMENDMENT AMENDMENT NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN -

NO FEES REQUIRED NO

} OTHER (Spedty)

TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF I DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS ,

FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE NEW REGISTRATION - ] MODUCT INAN -

ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY TYPE OF FEE FEE CATEGORY AuoVNT RECErVED

]9A 9B 9C 90 CHECK NUMBER MATANN UPDATED AS REQUIRED DATE OF CHECK LOG

] MATSYS UPDATED AS REQUIRED APPROVED BY DATE RETURN DATE COMMENTS NRC FORM $67 (6-03)

ORIGip!Al.TO SSSS

A B Et Mpp ASEA BROWN BOVERI August 13, 1993 U.S. NUCLEAR REGULATORY COMMISSION ATTN: John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety Washington, D.C. 20555-0001

Dear Mr. Lubinski:

Enclosed is the set of up-to-date engineering drawings from our sealed source suppliers which you requested in your letter of June 21, 1993 for the ABB sealed source models listed for our registered devices.

ABB Vendor Vendor Model Isotope Model Engineering Number Number Drawing , ,

S-11 Kr-85 KACK3349 3A62234 KACK4778 3A62234 KACQ4474 2A62643 NER-584 313-466 NER-587 313-360 l S-16 Am-241 AMCQ6477  !

BRC10412/S .

AMCQ6785 3A61648 l AMCK4754 3A61648 S-18 Sr-90 SIFQ2820 3A62094 SIFV328 3A61578 SIFQ6494 3A61578 SIFQ8213 2A61574 SIFW517 3A10236 SIFW518 3A10236 S-20 Pm-147 PHCK2026 3A62055 Sincerely, John R. Dukes, Manager Nucleonics & Radiological Operations encl: As stated cc: Radiological Operations i

ABB Process Automation Inc.

650 Ackerman Road Telephone Telex: Telefax P.O. Bon 02650 . 614/261 2000 246675 614761-2172 Columbus. Orno 432021502 y

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September 3), 1996 Mr. John R. Dukes ABB Process Automation 650 Ackerman Road Columbus, OH 43202-1502 4

Dear Mr. Dukes:

This is in response to your letters dated August 13,1993, and February 22,1996, notifying us of a change to add an alternate method of preventing the hermetically sealed inner capsule from rotating. We have amended attachment four on registration certificates' NR-109-D-121-B, NR-109-D-122-B and NR-109-D-124-B. Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modification to the information submitted to obtain the certificate. Please read over the enclosed registration certificate in its entirety and notify us immediately of any errors or omissions. You are obligated to notify us promptly in writing should you decide to no longer manufacture or offer service support for the product. Please be aware that, as a holder of a NRC registration, you may be subject to the NRC's licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544. If you have any questions, please contact me at (301) 415-7273. Sincerely, lSl Kim Randall, Registration Assistant , Sealed Source Safety Section l Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

As stated l cc: SKimberley, LFDCB (w/ encl.) Distribution SSSS r/f SSD 96-12 SSD 96-20 NEO1 SBaggett NR-109-D-121-B NR-109-D-122-B NR-109-D-124-B DOCUMENT NAME: NR109D121B

       *C" = Copy without attachment / enclosure 'E' = Copy w,th attachmente enclosure *N" = No copy OFFICE         IMAB ff                   l     lMAB (7                                        l         l NAME           KRandalf'                       SBaggstt DATE           9//596                          V M/96
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