Identity
- Trade Name
- VARIO-PORT FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- Adapters EUDAMEDREDUCTION ADAPTER for reduction from Ø 7mm, Ø 10mm and Ø 12.5 to Ø 5.5mm for RIWO-ART trocars, PACK=5 PCS, reusable FDA UDI
- Model / Reference
- 10000201308 EUDAMED8923.802 EUDAMED8923802 FDA UDI
- Description
- REDUCTION ADAPTER for reduction from Ø 7mm, Ø 10mm and Ø 12.5 to Ø 5.5mm for RIWO-ART trocars, PACK=5 PCS, reusable FDA UDI
Identifiers
- Catalog Number
- 8923.802 FDA UDI
- Primary DI / UDI-DI
- 04055207022481 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520717052019-0018383N2 EUDAMED
- Unit of Use DI
- 04055207059500 EUDAMED
- FDA Product Code
- FBQ FDA UDI
- EMDN Code
- L1218 LAPAROSCOPIC AND THORACOSCOPY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5090 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Adapters by Richard Wolf GmbH — Class I — 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 | 405520717052019-0018383N2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED d5fff5fd-cb8b-4e84-9de3-604c2bf4c2de 61 fields · synced May 30, 2026
- FDA UDI 27a7d1c0-ef76-4056-9f9c-fea94e43e581 35 fields · synced May 25, 2026