Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- [ARVIS] Hip and Knee EUDAMEDLandmark Punch FDA UDI
- Model / Reference
- IN-14700 EUDAMEDFDA UDI
- Description
- Landmark Punch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350532 EUDAMEDFDA UDI
- Basic UDI-DI
- 08889120000Z120114820A0GB EUDAMED
- Direct Marketing DI
- 00810180350532 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011482 SURGICAL NAVIGATION INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
[ARVIS] Hip and Knee by Kico Knee Innovation Company Pty Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08889120000Z120114820A0GB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kico Knee Innovation Company Pty Ltd
- EUDAMED SRN
- AU-MF-000011477
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 011f5117-0711-45d2-bd03-5ecc97733221 61 fields · synced Jun 17, 2026
- FDA UDI 946ae79b-eec8-4f08-b5db-a5772e28a583 33 fields · synced May 30, 2026