AccessGUDID - DEVICE: StaySure (00865453000331)

GUDID

Device Identifier (DI) Information

Brand Name: StaySure
Version or Model: 110104
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 110104
Company Name: Minnesota Medical Technologies Corporation

Primary DI Number: 00865453000331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 034186582 *Terms of Use

Device Description: Fecal Incontinence Insert, StaySure, 30-Pack, Standard

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):	Yes
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?
46193	Anal plug, single-use	A device designed to be inserted into the rectum by the user and retained there as a barrier to the passage of stool for the prevention of the involuntary evacuation of stool (faeces) in persons who are incontinent of bowel. It is typically made of plastic foam materials which expand upon contact with rectal moisture; it is available in a variety of sizes. The device may also be known as an anal tampon and is intended to be replaced after each rectal void. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBP	Rectal Insert

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243367	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: Standard

Device Record Status

Public Device Record Key: ac6289cb-f502-48e8-bc9b-6393e1111986
Public Version Date: March 31, 2026
Public Version Number: 1
DI Record Publish Date: March 23, 2026