Identity
- Trade Name
- Hermann Medizintechnik GmbH FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- High Flow Hysteroscopy sheath, ø5,5mm,with instrument channel 5Ch., 2 rotatablestopcocks, working length 200mm, outer Ø 6,5mm, to use with scope 2,7/2,9mm, 30° FDA UDI
- Model / Reference
- H51-091-006 FDA UDI
- Description
- High Flow Hysteroscopy sheath, ø5,5mm,with instrument channel 5Ch., 2 rotatablestopcocks, working length 200mm, outer Ø 6,5mm, to use with scope 2,7/2,9mm, 30° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059453061812 FDA UDI
- FDA Product Code
- NWW FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope sheath, reusable
Hermann Medizintechnik GmbH by Hermann Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hermann Medizintechnik GmbH
Sources (1)
- FDA UDI bd63cc7a-e90c-48f4-9f4a-4dfd26e62a3e 34 fields · synced Jun 8, 2026