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Twister™ Side-Fire Fiber Optic Delivery System

FDA UDI

Class II (US FDA UDI)

by Ceram Optec SIA

Identity

Trade Name
Twister™ Side-Fire Fiber Optic Delivery System FDA UDI
Generic Name
Urogenital surgical laser system beam guide, single-use FDA UDI
Model / Reference
Twister™ XL FDA UDI

Identifiers

Catalog Number
101300 FDA UDI
Primary DI / UDI-DI
04049089100207 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Urogenital surgical laser system beam guide, single-use 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

Category: Urogenital surgical laser system beam guide, single-use

A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications.

Similar devices

Also classified as Urogenital surgical laser system beam guide, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ceram Optec SIA

Sources (1)

  • FDA UDI 37ba723b-68e4-4b0b-943e-e67a547769fe 33 fields · synced Jun 24, 2026