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Gemini

FDA UDI

Class I (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Gemini FDA UDI
Generic Name
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Device Name
The Gemini-Double Ended Channel cleaning brush is a nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from flexible endoscopes. FDA UDI
Model / Reference
00711607 FDA UDI
Description
The Gemini-Double Ended Channel cleaning brush is a nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from flexible endoscopes. FDA UDI

Identifiers

Catalog Number
00711607 FDA UDI
Primary DI / UDI-DI
00724995184964 FDA UDI
FDA Product Code
MNL FDA UDI
GMDN Term
Surgical instrument/endoscope cleaning utensil, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical instrument/endoscope cleaning utensil, single-use

Gemini by US Endoscopy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument/endoscope cleaning utensil, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI 02516a9f-40db-450b-a29e-85fcb248462c 35 fields · synced May 30, 2026