AccessGUDID - DEVICE: ESTEEM SYNERGY+ (00768455114689)

GUDID

Device Identifier (DI) Information

Brand Name: ESTEEM SYNERGY+
Version or Model: 416782
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455114689
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: Esteem Synergy®+ Standard Closed End Pouch W/Filter / One-Sided Comfort Panel / Transparent / Large

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):	No
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?
31067	Multiple-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZQ	POUCH, COLOSTOMY

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: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 6531021e-76be-40ff-a11e-48b11215a83f
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022