AccessGUDID - DEVICE: OstomyGel (07898616351431)

GUDID

Device Identifier (DI) Information

Brand Name: OstomyGel
Version or Model: 290010003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 290010003
Company Name: DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA

Primary DI Number: 07898616351431
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 904563269 *Terms of Use

Device Description: Ostomy accessory

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
37592	Ostomy odour-absorbent/deodorizer	A device used by an ostomate to absorb unwanted odours and/or emit fragrance to conceal any unpleasant odours emanating from their stoma/ostomy devices. It is available in various forms, such as a powder with anti-odour properties (e.g., Zeolite) or a portable spray, for convenient daily use. After application this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDS	Bag, Stomal

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: d61d517c-a448-4c78-a133-8b38918a23ad
Public Version Date: May 06, 2025
Public Version Number: 1
DI Record Publish Date: April 28, 2025