Identity
- Trade Name
- ARVIS ® FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Instrument Tray Base EUDAMEDInstrument Tray Base, Shoulder FDA UDI
- Model / Reference
- IN-21100 EUDAMEDFDA UDI
- Description
- Instrument Tray Base, Shoulder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810180350365 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888912000000S0104010B0RF EUDAMED
- Direct Marketing DI
- 00810180350365 EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Italy 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
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
Category: Instrument tray, reusable
Arvis ® by Kico Knee Innovation Company Pty Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Kico Knee Innovation Company Pty Limited
Sources (2)
- FDA UDI 28d2083b-b375-4774-8dea-7368ec40f2c3 33 fields · synced Oct 6, 2026
- EUDAMED a23f3fde-67c3-4da6-aa16-3a0b204d72f2 61 fields · synced Jul 31, 2026