Identity
- Trade Name
- Best Medical International FDA UDI
- Generic Name
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- 7001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841365118593 FDA UDI
- 510(k) Number
- K042586 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Breast brachytherapy system applicator, remote-afterloading
Best Medical International by Best Medical International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast brachytherapy system applicator, remote-afterloading.
- Mammosite Cavity Evaluation Device Kit (CED) — Hologic, Inc. · Class II
- ATEC — Hologic, Inc. · Class I
- ATEC — Hologic, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Best Medical International, Inc.
Sources (1)
- FDA UDI 8e0374dd-7e9a-4c23-bcb5-08f75b2e1de8 33 fields · synced Jun 9, 2026