ML20217N141
| ML20217N141 | |
| Person / Time | |
|---|---|
| Site: | (NR-1047-D-101-E, SSD-98-07) |
| Issue date: | 02/09/1998 |
| From: | Randall K NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Guo V External (Affiliation Not Assigned) |
| Shared Package | |
| ML20217N146 | List: |
| References | |
| SSD, NUDOCS 9805050238 | |
| Download: ML20217N141 (4) | |
Text
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t UNITED STATES g
j NUCLEAR RECULATORY COMMICSION r
WASHINGTON, D.C. 20e164001 l
February 9,'1998 Ms. Vivian Guo, President OUR Scientific Intemational, Inc.
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One World Trade Center Suite 7871 New York, NY 10048
Dear Ms. Guo:
This ietter is in response to your application dated January 7,1998, requesting registration of OUR XGD Rotating Gamma System, Model 11. Please note that you are located in an Agreement State. Agreement States are responsible for performing the safety evaluation of products. You should submit your application to Ms. Rita Aldrich in the State of New York, Division of Safety and Health, New York State Department of Labor, New York State Office Campus, Building 12, Room 457, Albany, NY 12240, (518) 457-1202. We did note some deficiencies in your application that you may want to review / address before submitting the application to the State of New York. These are as follows:
1.
Complete and detailed engineering drawings including dimensions, tolerances, materials of construction, and assembly methods (screw, welds, etc.).
2.
A copy or description of the label, and describe the placement, materials of jconstruction and means of attachment of the label.
3.
The resuits of prototype testing that demonstrate the effectiveness of the containment, shielding, and the safety features under both normal and likely accidental conditions of use and disposal of this product. Please provide the tests and procedures used.
4.
Radiation profiles around the device at of 5,30, and 100 cm.
5.
Describe what procedures are taken to ensure that your product is manufactured and distributed in accordance with the representations made in your application. Specific details of Quality Control and Quality Assurance program.
6.
Operations / Users / Safety instructions were not included in your application. Please provide instructions involving the operation, maintenance, calibration, damage / failure, specific wamings, and radiation surveying of the product.
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We nave enclosed NUREG-1550 and NUREG-1556 Vol.3 for your use.
Sincerely, b
KimBerly Rand'all, Sealed Source Device ~ Assistant Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety-Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc: Rita Aldrich, State of New York Sandra Kimberley, LFDCB Richard Bangart, OSP Distributiom NEO2-SSD-2 IMNS r/f DOCUMENT NAME PSGUO
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I PAGE1 NRC FORM 567 U. S. NUCLEAR REGL' -TORY COMMISSION
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REQUEST FOR A SEALED SOURCE OR DEVICE EVALUATION INSTRUCTIONS: Send tNo request AND e copy of all related e and drawin0s to: The Seeled Source Safety Section, ATTN: CNef, OWFN Mall Stop 6 H3. Change the License Tracidng System milestone to 19 and eseign to reviewer code I-5.
NOTE: Retain a copy of tNs request with the appliW and background filee.
REQUESTER REGION / LOCATION:
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'E/f AI/W / li 11 Ill IV V R HQ O LFDCB TELEPHONE NUMeER DATE TYPE OF ACTION REQUESTED (Check se - V es NAME SOURCE REVIEW AMENDMENT OF l[i Yr'ct/7 70.6 REGISTRATION SHEET MAIL CONTROL NUMesR(S)
DEVICE REVIEW NUMBER (S)
LETTER /APPUCfTONpATE UCENSE NUMeER S)
CUSTOM REVIEW I/'7/97
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FOlt SSSS USE OIA.Y REvewER MooEL NuuseRs mae y NuMeER AssoNED 98 0 7 DATE RFCErVED DATE ASeONED DATE TO FEES ihaMM
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TYPE OF ACTION (Indcate the number of each type)
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l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPUCANT(CUSTOM)
SOURCE (9C)
DEVICE (SA)
SOURCE (90)
DEVICE (98)
]NEW 2IEW
]NEW
] NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT j NO SAFETY EVALUATION REQUIRED j UCENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED
] OTHER (SpecWy)
TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS FOR SILUNG PURPOSES ONLY j NEW REGISTRATION-
_j PRODUCT INACTIVE -
NAME CHANGE ADDRESS CHANGE ADD TO BILLING REMOVE FROM BILUNG FOR FEE USE ONLY 1YPE OF FEE FEE CATEGORY l9A 9B
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9C 90 AMOUNT RECEn/ED CHECK NUMeER MATANN UPDATED AS REQUIRED DATE OF CHECK LCG J MATSYS UPDATED AS REQUIRED APPROVED oY DATE RETURN DATE m m FMTS NRC FORM 667 (8-e3)
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PAGE1 NRC FORM 567 U. S. NUCLEAR REGULATORY COMMISSION
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REQUEST FOR A SEALED SOURCE OR r
DEVICE EVALUATION INSTRUCTIONS: Send this request AND a copy of all related letters /apphcations and drawings to: The Sealed Source Safety Section, ATTN: Chef, OWFN Mail Stop 6 H3. Change the License Tracking System milestone to 19 and assign to reviewer code 1-5.
NOTE: Retain a copy of this request wtth the apphcation and background flies.
REoVEsTER REGION / LOCATION:
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6>1bNIC 3A Al*#/ li R 11 Rlil IV RV R HQ R LFDCB TELEPHONE NUMBER DATE TYPE OF ACTION REQUESTED (Check as appropriate)
APPUCANT'8 NAME SOURCE REVIEW
] AMENDMENT OF
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REGISTRATION SHEET MAIL CONTROL NUMBfR(S)
DEVICE REVIEW N BENS)
LETTER /AP48UCATM PATE LICENSE NUMBER (S)
CUSTOM REVIEW
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A a~ pK, & I a3 W FOR SSSS USE ONLY REVIEWER MODEL Or ABERS NUMBER ASSIGNED 9
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DATE RECENED DATE AS$1GNED DATE TO FEES
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TYPE OF ACTION (Indicate the number of each type)
/
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l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM)
SOURCE (9C)
DEVICE (9A)
SOURCE (9D)
DEVICC (98)
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NEW
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NEW NEW AMENDMENT AMENDMENT AMENDMENT AMENDMENT s
j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN NO NO FEES REQUIRED j OTHER (Specty)
TOTAL NUMBER OF NOTES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF DEFICIENCY CALLS
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FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE NEW REGISTRATION -
] MODUCT INACM -
ADD TO BILLING REMOVE FROM BILLING o
FOR FEE USE ONLY WPE OF FEE FEE CATEGORY
]9A BB 9C 9D AMOUNT RECEIVED CHECK NUMBER MATANN UPDATED AS REQUIRED DATE OF CHECK LOG
] MATSYS UPDATED AS REQUIRED APPROVED By DATE RETURN DATE b
COMMENTS p.,
NRC FONM 667 (6-93)
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