Identity
- Trade Name
- 1.5MM/2.0MM SYSTEM FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Model / Reference
- 01-9095 FDA UDI
Identifiers
- Catalog Number
- 01-9095 FDA UDI
- Primary DI / UDI-DI
- 00841036016791 FDA UDI
- FDA Product Code
- HTD FDA UDIHRS FDA UDIJEY FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI888.3030 FDA UDI872.4760 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
1.5mm/2.0mm System by Biomet Microfixation, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
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
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI 7b8e449f-f54c-4f09-89b2-0b3e5833f93d 34 fields · synced Jun 6, 2026