Identity
- Trade Name
- RZ Medizintechnik GmbH FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- Cutting Electrode, 24 Charr., 30°, angled, yellow/blue HYBRID, steril, package of 6 pieces FDA UDI
- Model / Reference
- 253-400-202S FDA UDI
- Description
- Cutting Electrode, 24 Charr., 30°, angled, yellow/blue HYBRID, steril, package of 6 pieces FDA UDI
Identifiers
- Catalog Number
- 253-400-202S FDA UDI
- Primary DI / UDI-DI
- 04049197517058 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
Similar devices
Also classified as Endoscopic electrosurgical electrode, bipolar, single-use.
- Olympus — Olympus Winter & Ibe GmbH · Class II
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- Virtuosaph Plus Endoscopic Vessel Harvester — Terumo Cardiovascular Systems Corporation · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- ACE — ACE MEDICAL DEVICES PRIVATE LIMITED · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RZ-Medizintechnik GmbH
Sources (1)
- FDA UDI 86512770-67db-4404-b7f9-607a61eef196 36 fields · synced May 29, 2026