GI Genius

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: GI Genius FDA UDI
Generic Name: Endoscopic video image interpretive unit FDA UDI
Device Name: Intelligent Endoscopy Module , Refurbished FDA UDI
Model / Reference: CB1708-RFB FDA UDI
Description: Intelligent Endoscopy Module , Refurbished FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521821545 FDA UDI
FDA Product Code: QNP FDA UDI
GMDN Term: Endoscopic video image interpretive unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image interpretive unit

GI Genius by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image interpretive unit.

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GI Genius™ Module 100 — LINKVERSE SRL · Class II
MAGENTIQ-COLO (ME-APDS) — MAGENTIQ EYE LTD · Class II
SKOUT system — Iterative Scopes, Inc. · Class II
GI Genius — Covidien LP · Class II
GI Genius — Covidien LP · Class II

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: Covidien LP

Sources (1)

FDA UDI 919e1636-6bd1-4ad5-bcd1-be1369a0e136 35 fields · synced May 30, 2026