← Back to catalogue

Flexguide Ultra Handpiece

FDA UDI

Class II (US FDA UDI)

by Omniguide, Inc.

Identity

Trade Name
Flexguide Ultra Handpiece FDA UDI
Generic Name
Urogenital surgical laser system beam guide, reusable FDA UDI
Device Name
BeamPath Robotic Fiber Conduit FDA UDI
Model / Reference
FLEXGUIDE-ULTRA FDA UDI
Description
BeamPath Robotic Fiber Conduit FDA UDI

Identifiers

Catalog Number
FLEXGUIDE-ULTRA FDA UDI
Primary DI / UDI-DI
00894338002016 FDA UDI
510(k) Number
K140378 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Urogenital surgical laser system beam guide, reusable 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Urogenital surgical laser system beam guide, reusable

Flexguide Ultra Handpiece by Omniguide, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urogenital surgical laser system beam guide, reusable.

Cleared under the same submission

K140378 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Omniguide, Inc.

Sources (1)

  • FDA UDI bb9e7b46-7739-4eeb-8c9b-abdcedbc959f 35 fields · synced Jun 6, 2026