AWCduo

FDA UDI

Class I (US FDA UDI)

by Ovesco Endoscopy AG

Identity

Trade Name: AWCduo FDA UDI
Generic Name: Endoscope channel support kit FDA UDI
Device Name: The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: flexible cap (for endoscope diameters from 11.5 mm to 13.5 mm) | AWCduo working channel with connector and valve with Luer Lock connection | AWCduo mounting clasp with fastening strap for fixation at the endoscope handle | endoscope sleeve | adhesive tapes for fixation • for gastroscopes with insertion length of 160 - 170 cm FDA UDI
Model / Reference: 184 cm FDA UDI
Description: The AWCduo is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: flexible cap (for endoscope diameters from 11.5 mm to 13.5 mm) | AWCduo working channel with connector and valve with Luer Lock connection | AWCduo mounting clasp with fastening strap for fixation at the endoscope handle | endoscope sleeve | adhesive tapes for fixation • for gastroscopes with insertion length of 160 - 170 cm FDA UDI

Identifiers

Catalog Number: 200.57.06 FDA UDI
Primary DI / UDI-DI: 04260206311935 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Endoscope channel support kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope channel support kit

AWCduo by Ovesco Endoscopy AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Ovesco Endoscopy AG

Sources (1)

FDA UDI 9b940f99-155b-417a-9650-4d4bc567f35c 36 fields · synced May 30, 2026