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ACS® Uni joint gap feeler
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 42160710Model KNU13HFRINSTRef 42161755Model KNU15JGFINSTRef 42160268Model KNU15JGCINSTRef 42160342Model KNU7SGRGINSTRef 42160734Model KNU12UPEINSTRef 42160513Model KNU12UTTTCINSTRef 42161709Model KNU14AIMAINST
Identity
- Trade Name
- ACS® UNI EUDAMEDACS® Uni joint gap feeler FDA UDIACS® UNI LD femoral component cemented FDA UDIACS® Uni handle for femoral resection guide FDA UDIACS® Uni Reamer guide FDA UDIACS® Uni IM adapter FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDIUncoated unicondylar knee femur prosthesis FDA UDISurgical instrument handle, non-torque-limiting FDA UDIOrthopaedic reamer guide FDA UDIOrthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- - EUDAMED
- Model / Reference
- 42161755 EUDAMEDFDA UDI42160710 EUDAMEDFDA UDI42160342 EUDAMEDFDA UDI42161709 EUDAMEDFDA UDIKNU13HFRINST EUDAMEDKNU15JGFINST EUDAMEDKNU15JGCINST EUDAMED42160268 EUDAMEDKNU7SGRGINST EUDAMEDKNU12UPEINST EUDAMED42160734 EUDAMEDKNU12UTTTCINST EUDAMED42160513 EUDAMEDKNU14AIMAINST EUDAMED42062102 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844440589 EUDAMEDFDA UDI04048844233570 EUDAMEDFDA UDI04048844478001 EUDAMEDFDA UDI04048844435295 EUDAMEDFDA UDI04048844140045 EUDAMED04048844233747 EUDAMED04048844134761 EUDAMED04048844128586 FDA UDI
- Basic UDI-DI
- 4048844KNU13HFRINST9S EUDAMED4048844KNU15JGFINST8B EUDAMED4048844KNU15JGCINST7A EUDAMED4048844KNU7SGRGINSTZ3 EUDAMED4048844KNU12UPEINSTFP EUDAMED4048844KNU12UTTTCINSTS7 EUDAMED4048844KNU14AIMAINSTWG EUDAMED
- Direct Marketing DI
- 04048844233570 EUDAMED04048844440589 EUDAMED04048844140045 EUDAMED04048844478001 EUDAMED
- FDA Product Code
- LXH FDA UDIHSX FDA UDI
- EMDN Code
- L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMEDL0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMEDL0317 GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDIUncoated unicondylar knee femur prosthesis FDA UDISurgical instrument handle, non-torque-limiting FDA UDIOrthopaedic reamer guide FDA UDIOrthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.3520 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMEDTürkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDIFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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 UDIFDA 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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, reusable
ACS® Uni joint gap feeler by implantcast GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.
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- General Instruments — ALPHATEC SPINE, INC. · Class I
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (12)
- FDA UDI a6341689-39b8-4386-a767-588cfa1e4c69 33 fields · synced Jul 16, 2026
- FDA UDI 184a6899-bc18-428d-b088-17857de69a00 33 fields · synced May 25, 2026
- FDA UDI 8aeae543-7b0f-4dd6-a558-4b143829f0bf 32 fields · synced May 29, 2026
- FDA UDI 0648f333-0eb2-4ad2-9845-909ee696d0e7 33 fields · synced May 30, 2026
- FDA UDI 699ef288-0ab9-4b0d-96a7-11cb9d0c6e1d 32 fields · synced May 30, 2026
- EUDAMED bebe1a83-1ad0-471f-86bc-7f54719b7f1c 61 fields · synced Jul 8, 2026
- EUDAMED d8dd3252-b8cb-4e91-9a3f-78db5e01b4eb 61 fields · synced Jul 8, 2026
- EUDAMED 67ea5076-37a1-49d2-ba62-d46be377b08c 61 fields · synced Jul 8, 2026
- EUDAMED 710537ac-52f0-411e-bb94-b128dd643c40 61 fields · synced Jul 8, 2026
- EUDAMED dd214add-03d6-4986-bb8c-caa6e6e39e80 61 fields · synced Jul 8, 2026
- EUDAMED 5ad9a32f-4537-4687-a8e4-ac394299c0ba 61 fields · synced Jul 8, 2026
- EUDAMED e71d86de-ce21-4e73-a8ba-d1f5b36d9412 61 fields · synced Jul 16, 2026