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[ARVIS - Instruments] Femoral Cutting Block
EUDAMEDFDA UDIClass I (EU MDR)
Ref IN-15600
Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- [ARVIS - Instruments] Femoral Cutting Block EUDAMEDFemoral Cutting Block FDA UDI
- Model / Reference
- IN-15600 EUDAMEDFDA UDI
- Description
- Femoral Cutting Block FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350402 EUDAMEDFDA UDI
- Basic UDI-DI
- 088891200000000L09220A0CW EUDAMED
- Direct Marketing DI
- 00810180350402 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
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
No
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 - Instruments] Femoral Cutting Block by Kico Knee Innovation Company Pty Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 088891200000000L09220A0CW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kico Knee Innovation Company Pty Ltd
- EUDAMED SRN
- AU-MF-000011477
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 8c21932c-844f-47a1-8637-9f8cc75a70f6 61 fields · synced Jul 25, 2026
- FDA UDI 17bb4318-27f1-4779-839a-fec0401c8a43 33 fields · synced May 30, 2026