Identity
- Trade Name
- Hysteroscopy obturator FDA UDI
- Generic Name
- Rigid endoscope obturator FDA UDI
- Model / Reference
- 191 203 046BC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082006062 FDA UDI
- 510(k) Number
- K945265 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Rigid endoscope obturator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Rigid endoscope obturator
Hysteroscopy obturator by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K945265 also covers:
- Accessory for gynecology — SOPRO-COMEG GmbH
- Accessory for gynecology — SOPRO-COMEG GmbH
- Cystoscopy instrument — SOPRO-COMEG GmbH
- Cystoscopy instrument — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
- Hysteroscope — SOPRO-COMEG GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI aabc858c-cf79-4175-969d-f23667dfeea2 33 fields · synced Jun 1, 2026