AccessGUDID - DEVICE: Safe N Simple (00810040134784)

GUDID

Device Identifier (DI) Information

Brand Name: Safe N Simple
Version or Model: SNS7204134-NF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SNS7204134-NF
Company Name: SAFE N' SIMPLE LLC

Primary DI Number: 00810040134784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 807812412 *Terms of Use

Device Description: 4 1/4" x 4 1/4" 2- Piece Wafer Standard Wear Tape Collar White 50 mm 2" Flange Cut to Fit

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?
48159	Intestinal ostomy base plate, flat	A non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. 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
No Device Sizes

Device Record Status

Public Device Record Key: d08d2526-40fa-4372-a815-7c9efc67925b
Public Version Date: May 13, 2025
Public Version Number: 2
DI Record Publish Date: November 08, 2024