Identity
- Trade Name
- Brachy Needle Box Template B-K FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- Brachy Needle Box Template B-K FDA UDI
- Model / Reference
- D0802002B FDA UDI
- Description
- Brachy Needle Box Template B-K FDA UDI
Identifiers
- Catalog Number
- D0802002B FDA UDI
- Primary DI / UDI-DI
- 00801741079153 FDA UDI
- 510(k) Number
- K972152 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General-purpose brachytherapy system applicator, manual
Brachy Needle Box Template B-K by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose brachytherapy system applicator, manual.
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Cleared under the same submission
K972152 also covers:
- Brachy Cart Table Mount — C. R. Bard, Inc.
- Brachy Column Extension — C. R. Bard, Inc.
- Brachy Insert Blank HDR Grid — C. R. Bard, Inc.
- Brachy Needle Box Template Siemens — C. R. Bard, Inc.
- Brachy Needle Template B-K — C. R. Bard, Inc.
- Brachy Needle Template B-K — C. R. Bard, Inc.
- Brachy Needle Template Siemens — C. R. Bard, Inc.
- Brachy Needle Template Siemens — C. R. Bard, Inc.
- Brachy Probe Cradle B-K 8848 — C. R. Bard, Inc.
- Brachy Probe Cradle GE ERB — C. R. Bard, Inc.
- Sure-Point™ — C. R. Bard, Inc.
- Sure-Point™ — C. R. Bard, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI 298ca33f-e2cd-4443-8c20-21b186960cf2 36 fields · synced May 30, 2026