Identity
- Trade Name
- Flex-X FDA UDI
- Generic Name
- Flexible fibreoptic ureterorenoscope FDA UDI
- Device Name
- Uretero-Reno-Fiberscope FLEX-X² FDA UDI
- Model / Reference
- 11278A2 FDA UDI
- Description
- Uretero-Reno-Fiberscope FLEX-X² FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551402573 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible fibreoptic ureterorenoscope 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Flexible fibreoptic ureterorenoscope
Flex-X by Karl Storz GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic ureterorenoscope.
- COBRA — Richard Wolf GmbH · Class II
- PENTAX — HOYA CORPORATION · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- VIPER — Richard Wolf GmbH · Class II
- FIBER URETEROSCOPE — PENTAX of America, Inc. · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
- URETERO-RENO FIBERSCOPE — Olympus Medical Systems Corporation · Class II
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
- Karl Storz GmbH & Co. KG
Sources (1)
- FDA UDI 6eac63ff-7132-45fc-8990-03c319a21ded 33 fields · synced May 30, 2026