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ACS® Uni IM adapter
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 42161709Model KNU14AIMAINST
Identity
- Trade Name
- ACS® UNI EUDAMEDACS® Uni IM adapter FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- - EUDAMED
- Model / Reference
- 42161709 EUDAMEDFDA UDIKNU14AIMAINST EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048844435295 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048844KNU14AIMAINSTWG EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
ACS® Uni IM adapter by implantcast GmbH — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — 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
- implantcast GmbH
Sources (2)
- FDA UDI 699ef288-0ab9-4b0d-96a7-11cb9d0c6e1d 32 fields · synced Oct 7, 2026
- EUDAMED e71d86de-ce21-4e73-a8ba-d1f5b36d9412 61 fields · synced Jul 16, 2026