Identity
- Trade Name
- Fibernex FDA UDI
- Generic Name
- Laser lithotripsy system FDA UDI
- Device Name
- Fibernex 200 micrometer Reusable Holmium Laser Fiber FDA UDI
- Model / Reference
- LF0201X200 FDA UDI
- Description
- Fibernex 200 micrometer Reusable Holmium Laser Fiber FDA UDI
Identifiers
- Primary DI / UDI-DI
- B050LF0201X2000 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Laser lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 200 Micrometer FDA UDI
Fibernex by Typenex Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Typenex Medical, LLC
Sources (1)
- FDA UDI 9358fad4-e687-42c5-8717-5c2fd0b1b2b8 36 fields · synced May 30, 2026