AccessGUDID - DEVICE: EndoRings (07290016767025)

GUDID

Device Identifier (DI) Information

Brand Name: EndoRings
Version or Model: E102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ENDOAID LTD

Primary DI Number: 07290016767025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600318101 *Terms of Use

Device Description: The EndoRings is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following: Keeping the suitable depth of endoscope's view field.

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":	No
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?
60911	Colonic endoscopy cuff	A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FED	Endoscopic Access Overtube, Gastroenterology-Urology

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
Height: 24 Millimeter
Device Size Text, specify: Ø50mm

Device Record Status

Public Device Record Key: 8668b791-4067-44a4-af0e-b5d9038c72b5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 27, 2016