Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Obturators EUDAMEDPROCTOSCOPE OBTURATOR Ø 10MM TL 159MM TL 159mm, reusable FDA UDI
- Model / Reference
- 10000201239 EUDAMED8836.057 EUDAMED8836057 FDA UDI
- Description
- PROCTOSCOPE OBTURATOR Ø 10MM TL 159MM TL 159mm, reusable FDA UDI
Identifiers
- Catalog Number
- 8836.057 FDA UDI
- Primary DI / UDI-DI
- 04055207043486 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018190PA EUDAMED
- Direct Marketing DI
- 04055207043486 EUDAMED
- FDA Product Code
- GCM FDA UDI
- EMDN Code
- L0406 RIGID RECTOSCOPES AND ANOSCOPES, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
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
Dimensions & Sizes
- Size
- Length — 159 Millimeter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Obturators 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 | 405520727052019-0018190PA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 59a6bf3b-7e00-46ae-a982-8247b276c981 61 fields · synced Jun 1, 2026
- FDA UDI 892fd3e9-d882-436d-a043-1b67e0fe1386 37 fields · synced May 30, 2026