Identity
- Trade Name
- Best Medical International FDA UDI
- Generic Name
- Manual brachytherapy source, permanent implant FDA UDI
- Model / Reference
- 10113-21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841365106972 FDA UDI
- 510(k) Number
- K912170 FDA UDI
- FDA Product Code
- IWI FDA UDI
- GMDN Term
- Manual brachytherapy source, permanent implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual brachytherapy source, permanent implant
Best Medical International by Best Medical International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual brachytherapy source, permanent implant.
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- TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
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Cleared under the same submission
K912170 also covers:
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, Inc.
- Best Medical International — Best Medical International, 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
- Best Medical International, Inc.
Sources (1)
- FDA UDI f70f6b39-6b1c-479c-a740-f9878f41ac11 33 fields · synced Jun 9, 2026