Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Metacarpal Lkg Plate Targ Guide, Left FDA UDI
- Model / Reference
- 80-0333 FDA UDI
- Description
- Metacarpal Lkg Plate Targ Guide, Left FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378041297 FDA UDI
- 510(k) Number
- K120903 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
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
Acumed by Acumed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120903 also covers:
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
- Acumed Llc
Sources (1)
- FDA UDI 0f48a325-eccd-4098-af35-ee02c4455ce4 36 fields · synced Jun 1, 2026