Identity
- Trade Name
- ACS® Uni femoral sizing guide FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Model / Reference
- 42160712 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844233594 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable 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
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
Category: Orthopaedic implant aiming/guiding block, reusable
ACS® Uni femoral sizing guide by implantcast GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block, reusable.
- TriVerse Tibial Offset Cutting Block — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- MAXIM STEMMED TIBIAL MASK — Biomet Orthopedics, Inc. · Class I
- VISIONAIRE — Smith & Nephew, Inc. · Class II
- INBONE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- Oxford Uni Knee System — Biomet Uk Ltd · Class I
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Journey — Smith & Nephew, Inc. · Class I
- Unity Total Knee System — CORIN LTD · Class II
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
- implantcast GmbH
Sources (1)
- FDA UDI 3373786f-bf5d-4caa-a9d7-30e87ed9a784 32 fields · synced Jun 1, 2026