AccessGUDID - DEVICE: Safe N Simple (00810040133435)

GUDID

Device Identifier (DI) Information

Brand Name: Safe N Simple
Version or Model: SNS7609002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SNS7609002
Company Name: SAFE N' SIMPLE LLC

Primary DI Number: 00810040133435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 807812412 *Terms of Use

Device Description: 9" Drainable One Piece Pouch Standard Wear Cut to Fit Transparent with Soft Tail Closure

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):	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?
31075	One-piece intestinal ostomy bag, open-ended	A plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZS	Appliance, Colostomy, Disposable

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
Length: 9 Inch

Device Record Status

Public Device Record Key: 0536e639-2230-4e8d-9b39-792e8c9abf04
Public Version Date: November 09, 2023
Public Version Number: 1
DI Record Publish Date: November 01, 2023