Identity
- Trade Name
- RZ Medizintechnik GmbH FDA UDI
- Generic Name
- Resectoscope FDA UDI
- Device Name
- Resectoscope Sheath, Continous Flow complete, 28 CH, rotatable, QL oblique ceramic tip, incl.253-000-268 FDA UDI
- Model / Reference
- 253-000-258 FDA UDI
- Description
- Resectoscope Sheath, Continous Flow complete, 28 CH, rotatable, QL oblique ceramic tip, incl.253-000-268 FDA UDI
Identifiers
- Catalog Number
- 253-000-258 FDA UDI
- Primary DI / UDI-DI
- 04049197178501 FDA UDI
- 510(k) Number
- K243382 FDA UDI
- FDA Product Code
- FAJ 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Resectoscope
RZ Medizintechnik GmbH by RZ-Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K243382 also covers:
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH
- RZ Medizintechnik GmbH — RZ-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
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI 091d420a-930b-4f19-9d1c-7922ae9d5572 36 fields · synced Jun 8, 2026