Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Device Name
- Obturators EUDAMEDOBTURATOR FOR HYSTEROSCOPE OD 5MM for WL 224mm, compatible with outer sheath 8988031 for diagnostic hysteroscopy, reusable FDA UDI
- Model / Reference
- 10000201273 EUDAMED8988.131 EUDAMED8988131 FDA UDI
- Description
- OBTURATOR FOR HYSTEROSCOPE OD 5MM for WL 224mm, compatible with outer sheath 8988031 for diagnostic hysteroscopy, reusable FDA UDI
Identifiers
- Catalog Number
- 8988.131 FDA UDI
- Primary DI / UDI-DI
- 04055207023709 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520711032019-0018273AE EUDAMED
- Direct Marketing DI
- 04055207023709 EUDAMED
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- L060408 ENDOSCOPIC UROLOGY FILLERS, REUSABLE EUDAMED
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 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
Dimensions & Sizes
- Size
- Outer Diameter — 5 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 | 405520711032019-0018273AE | 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 b3b02e08-1358-4519-9d4c-42ad5f95d944 61 fields · synced Jun 6, 2026
- FDA UDI b74738c2-66dc-4437-9807-950307045356 36 fields · synced May 29, 2026