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Sealing adapters and sealing caps
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8385.903Model 10000201265
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical irrigation/aspiration handpiece, reusable FDA UDI
- Device Name
- Sealing adapters and sealing caps EUDAMEDSEALING ATTACHMENT for suction irrigation handle 8385.901 with lumen and membrane valve, for auxiliary instruments up to 5mm, reusable FDA UDI
- Model / Reference
- 10000201265 EUDAMED8385.903 EUDAMED8385903 FDA UDI
- Description
- SEALING ATTACHMENT for suction irrigation handle 8385.901 with lumen and membrane valve, for auxiliary instruments up to 5mm, reusable FDA UDI
Identifiers
- Catalog Number
- 8385.903 FDA UDI
- Primary DI / UDI-DI
- 04055207015377 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520717052019-0018264MR EUDAMED
- Direct Marketing DI
- 04055207015377 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER 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 | 405520717052019-0018264MR | 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 a61c6438-da51-4a58-9412-720622b47dba 61 fields · synced Jun 19, 2026
- FDA UDI 0daf0b72-1a3b-4f17-a833-aada14d8d615 36 fields · synced May 30, 2026