Identity
- Trade Name
- ATTUNE FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- ATTUNE KNEE SYSTEM REVISION SYSTEM TORQUE HANDLE FDA UDI
- Model / Reference
- 2546-00-414 FDA UDI
- Description
- ATTUNE KNEE SYSTEM REVISION SYSTEM TORQUE HANDLE FDA UDI
Identifiers
- Catalog Number
- 254600414 FDA UDI
- Primary DI / UDI-DI
- 10603295440468 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
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
Attune by Depuy (ireland) — 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
- Depuy (ireland)
Sources (1)
- FDA UDI 13fc9fbf-6fa1-42bb-84fd-a13e32f7a2d2 36 fields · synced May 31, 2026