Identity
- Trade Name
- AcuMatch FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- TRIAL, NECK, HIGH OFFSET,+0mm, M-SERIES FDA UDI
- Model / Reference
- 151-01-01 FDA UDI
- Description
- TRIAL, NECK, HIGH OFFSET,+0mm, M-SERIES FDA UDI
Identifiers
- Catalog Number
- 151-01-01 FDA UDI
- Primary DI / UDI-DI
- 10885862028969 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
AcuMatch by Exactech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Exactech, Inc.
Sources (1)
- FDA UDI e160b29c-1056-4398-ae06-79bff5a0886e 36 fields · synced Jun 1, 2026