AWC

Basic Information

• Brand Name: AWC
• Primary DI: 04260206310976
• Version / Model: 185 cm
• Catalog Number: 200.57.04
• Company Name: Ovesco Endoscopy AG
• Labeler DUNS: 344007369
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-28
• Public Version: 3
• Public Version Date: 2019-10-31
• Public Version Status: Update
• Public Device Record Key: e5ca7f65-0fc0-48f9-8fe8-5ba0ebe1a959

Device Description

The AWC is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: distal attachment (cap) | shaft | adaptor for fixation at the endoscope handle | sleeve | valve and Luer Lock connection | tapes for fixation • for colonoscopes with insertion length of 160 - 170 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260206310969	GS1	Folding box	2	In Commercial Distribution
Primary	04260206310976	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			for instruments with max. diameter of 2.8 mm
Device Size Text, specify			for endoscopes with diameter 8.5 - 13.5 mm
Device Size Text, specify			working length 185 cm