Identity
- Trade Name
- EZLOC FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Model / Reference
- 904778 FDA UDI
Identifiers
- Catalog Number
- 904778 FDA UDI
- Primary DI / UDI-DI
- 00880304460447 FDA UDI
- 510(k) Number
- K053461 FDA UDI
- FDA Product Code
- HWC FDA UDIMBI FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone awl, reusable
Ezloc by Biomet Sports Medicine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053461 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
- Biomet Sports Medicine
Sources (1)
- FDA UDI cd6c558a-ca3a-4fff-ae71-dbcc858e96a1 36 fields · synced May 30, 2026