Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Pin-indexed adaptor, reusable FDA UDI
- Device Name
- Working inserts EUDAMEDWORKING INSERT FOR TEM for main element 8840.20 and silicone sealing insert 8840.242, reusable FDA UDI
- Model / Reference
- 10000201293 EUDAMED8840.241 EUDAMED8840241 FDA UDI
- Description
- WORKING INSERT FOR TEM for main element 8840.20 and silicone sealing insert 8840.242, reusable FDA UDI
Identifiers
- Catalog Number
- 8840.241 FDA UDI
- Primary DI / UDI-DI
- 04055207020906 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018349PP EUDAMED
- Direct Marketing DI
- 04055207020906 EUDAMED
- FDA Product Code
- GCM FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Pin-indexed adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Working inserts 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 | 405520727052019-0018349PP | 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 039cbcff-3c47-4712-9353-4981510bfedd 61 fields · synced Jul 12, 2026
- FDA UDI ad1b81f3-3644-4e71-a617-b061a4f567cb 35 fields · synced May 30, 2026