Identity
- Trade Name
- ATEC FDA UDI
- Generic Name
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- MME-00345 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045506411 FDA UDI
- FDA Product Code
- PYB FDA UDI
- GMDN Term
- Breast brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Breast brachytherapy system applicator, remote-afterloading
Atec by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast brachytherapy system applicator, remote-afterloading.
- Best Medical International — Best Medical International, Inc. · Class II
- Mammosite Cavity Evaluation Device Kit (CED) — Hologic, Inc. · Class II
- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI dc888b91-6658-48a3-a4a4-3402fe0aa98d 32 fields · synced May 31, 2026