Identity
- Trade Name
- RZ Medizintechnik GmbH FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- Cutting Loop Electrode 24 Ch., straight for 12/30° telescope yellow/blue for HYBRID Resectoscope, steril, 6 pcs FDA UDI
- Model / Reference
- 253-400-200S FDA UDI
- Description
- Cutting Loop Electrode 24 Ch., straight for 12/30° telescope yellow/blue for HYBRID Resectoscope, steril, 6 pcs FDA UDI
Identifiers
- Catalog Number
- 253-400-200S FDA UDI
- Primary DI / UDI-DI
- 04049197517041 FDA UDI
- 510(k) Number
- K243382 FDA UDI
- FDA Product Code
- FAS FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Radiation Sterilization FDA UDI
Category: Endoscopic electrosurgical electrode, bipolar, single-use
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 a189b5e2-788a-4793-bc81-54ce5a8f490d 36 fields · synced May 30, 2026