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Fibernex

FDA UDI

Class II (US FDA UDI)

by Typenex Medical, LLC

Identity

Trade Name
Fibernex FDA UDI
Generic Name
Laser lithotripsy system FDA UDI
Device Name
Fibernex 200µm Single Use Holmium Laser Fiber FDA UDI
Model / Reference
LF0101X200 FDA UDI
Description
Fibernex 200µm Single Use Holmium Laser Fiber FDA UDI

Identifiers

Primary DI / UDI-DI
B050LF0101X2000 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
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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 200 Micrometer FDA UDI

Category: Laser lithotripsy system

Fibernex by Typenex Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laser lithotripsy system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Typenex Medical, LLC

Sources (1)

  • FDA UDI ea082971-a842-4f18-b7ed-6ab971f95135 35 fields · synced May 30, 2026