Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Ulna intramedullary nail FDA UDI
- Device Name
- 4.0mm x 250mm Ulna Nail 2 FDA UDI
- Model / Reference
- 4011-4025N-S FDA UDI
- Description
- 4.0mm x 250mm Ulna Nail 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378110924 FDA UDI
- 510(k) Number
- K143276 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Ulna intramedullary nail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Category: Ulna intramedullary nail
Acumed by Acumed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ulna intramedullary nail.
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
- ACUMED — ACUMED LLC · Class II
Cleared under the same submission
K143276 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acumed Llc
Sources (1)
- FDA UDI d6fff6c8-6076-4665-9c73-7dd286891b0a 35 fields · synced May 30, 2026