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Sealing adapters and sealing caps
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8385.902Model 10000201263
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- Sealing adapters and sealing caps EUDAMEDSEALING CAP for suction irrigation handle 8385.901, reusable FDA UDI
- Model / Reference
- 10000201263 EUDAMED8385.902 EUDAMED8385902 FDA UDI
- Description
- SEALING CAP for suction irrigation handle 8385.901, reusable FDA UDI
Identifiers
- Catalog Number
- 8385.902 FDA UDI
- Primary DI / UDI-DI
- 04055207015360 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018262PA EUDAMED
- Direct Marketing DI
- 04055207015360 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1218 LAPAROSCOPIC AND THORACOSCOPY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
No
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
Sealing adapters and sealing caps 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 | 405520727052019-0018262PA | 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 167e2291-a95a-4a2d-a146-ed121de3902b 61 fields · synced Jul 9, 2026
- FDA UDI b770b1aa-5b5d-4a1a-9ed9-26e0fec2ce1b 36 fields · synced May 30, 2026