AccessGUDID - DEVICE: AWC (04260206310976)

GUDID

Device Identifier (DI) Information

Brand Name: AWC
Version or Model: 185 cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200.57.04
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310976
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZX	Guide, Surgical, Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: e5ca7f65-0fc0-48f9-8fe8-5ba0ebe1a959
Public Version Date: October 31, 2019
Public Version Number: 3
DI Record Publish Date: May 28, 2018