Identity
- Trade Name
- Hermann Medizintechnik GmbH FDA UDI
- Generic Name
- Resectoscope FDA UDI
- Device Name
- Continuous flow sheath with 2 stockcocks rotating, consist. of: 1 inner sheath19Charr. with ceramic insulation,1 outer sheath 22Charr. and 1 standard obturator FDA UDI
- Model / Reference
- H50-022-004 FDA UDI
- Description
- Continuous flow sheath with 2 stockcocks rotating, consist. of: 1 inner sheath19Charr. with ceramic insulation,1 outer sheath 22Charr. and 1 standard obturator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059453040152 FDA UDI
- 510(k) Number
- K051610 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Resectoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Category: Resectoscope
Hermann Medizintechnik GmbH by Hermann Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class II
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Cleared under the same submission
K051610 also covers:
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH
- Hermann Medizintechnik GmbH — Hermann Medizintechnik 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
- Hermann Medizintechnik GmbH
Sources (1)
- FDA UDI e281ea83-1df7-45a6-9088-9319223738cc 35 fields · synced Jun 8, 2026