Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Obturators EUDAMEDRECTOSCOPE-OBTURATOR Ø 18MM TL 328MM TL 328mm, reusable FDA UDI
- Model / Reference
- 10000201234 EUDAMED8834.027 EUDAMED8834027 FDA UDI
- Description
- RECTOSCOPE-OBTURATOR Ø 18MM TL 328MM TL 328mm, reusable FDA UDI
Identifiers
- Catalog Number
- 8834.027 FDA UDI
- Primary DI / UDI-DI
- 04055207043288 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018184PF EUDAMED
- Direct Marketing DI
- 04055207043288 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
- Outer Diameter — 18 Millimeter FDA UDILength — 328 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 | 405520727052019-0018184PF | 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 ee1f6588-de78-48b0-8d05-994e05662707 61 fields · synced Jun 6, 2026
- FDA UDI 488ec662-0e71-44a9-8b5c-efd6c0c9f64d 37 fields · synced May 29, 2026