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Sealing adapters and sealing caps
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89.161Model 10000201178
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Laparoscopic access cannula seal, reusable FDA UDI
- Device Name
- Sealing adapters and sealing caps EUDAMEDSEALING CAP CAP 7.5-8.5MM large for instruments with diameter 7,5 to 8,5 mm, colour: blue FDA UDI
- Model / Reference
- 10000201178 EUDAMED89.161 EUDAMED89161 FDA UDI
- Description
- SEALING CAP CAP 7.5-8.5MM large for instruments with diameter 7,5 to 8,5 mm, colour: blue FDA UDI
Identifiers
- Catalog Number
- 89.161 FDA UDI
- Primary DI / UDI-DI
- 04055207058985 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017854Q2 EUDAMED
- Unit of Use DI
- 04055207069967 EUDAMED
- FDA Product Code
- KNS FDA UDIHIF FDA UDIGCM FDA UDIFJL FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
- GMDN Term
- Laparoscopic access cannula seal, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI884.1730 FDA UDI876.1500 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
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 | 405520727052019-0017854Q2 | 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 beb6f12a-c934-457d-bd1d-440104b0d80e 61 fields · synced Jun 18, 2026
- FDA UDI b2bf101b-b807-4d7b-a7b8-78acc943e3c3 36 fields · synced May 30, 2026