AccessGUDID - DEVICE: Safe N Simple (00810040134005)

GUDID

Device Identifier (DI) Information

Brand Name: Safe N Simple
Version or Model: SNS7822134
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SNS7822134
Company Name: SAFE N' SIMPLE LLC

Primary DI Number: 00810040134005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 807812412 *Terms of Use

Device Description: 5" x 5" 2-Piece Wafer Extended Wear Convex with Tape Collar Beige 45mm 1 3/4" Flange 7/8" Pre Cut Stoma Opening

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?
48158	Intestinal ostomy base plate, convex	A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate 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. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. 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
Length: 5 Inch
Height: 5 Inch

Device Record Status

Public Device Record Key: 26b19d16-ef22-43ad-a2c9-8bb6e16394ff
Public Version Date: October 30, 2023
Public Version Number: 1
DI Record Publish Date: October 20, 2023