Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Device Name
- AM-5014-S, Acutrak® 4/5 Dense Drill, 5pk FDA UDI
- Model / Reference
- 45-0005-S FDA UDI
- Description
- AM-5014-S, Acutrak® 4/5 Dense Drill, 5pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20806378029124 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Drilling power tool attachment, basic
Acumed by Acumed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drilling power tool attachment, basic.
- Smith and Nephew — Provision · Class I
- Stryker — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- Synthes — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- GEO — Provision · Class I
- Synthes — Provision · Class I
- CrossRoads — Provision · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acumed Llc
Sources (1)
- FDA UDI 3980545c-7b11-478c-a138-1116f1de6536 34 fields · synced May 30, 2026