[ARVIS - Instruments] Precision Adjustable Distal Guide
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- [ARVIS - Instruments] Precision Adjustable Distal Guide EUDAMEDPrecision Adjustable Distal Guide FDA UDI
- Model / Reference
- IN-19100 EUDAMEDFDA UDI
- Description
- Precision Adjustable Distal Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350396 EUDAMEDFDA UDI
- Basic UDI-DI
- 088891200000000L09220A1CY EUDAMED
- Direct Marketing DI
- 00810180350396 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The ARVIS Precision Adjustable Distal Guide is a precision instrument used in orthopedic surgery to aid in the manipulation of joints and bones. This device features a unique adjustable distal guide that allows for precise movement, making it an essential tool for surgeons.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 088891200000000L09220A1CY | 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 b0078cbe-5b34-4590-9371-f39c7ee55015 61 fields · synced Jul 25, 2026
- FDA UDI 9458b191-99dc-4822-a446-8f8209d83979 33 fields · synced May 30, 2026