StaySure 110114

GUDID 00865453000324

Fecal Incontinence Insert, StaySure, Starter Pack

Minnesota Medical Technologies Corporation

Anal plug, single-use

• Primary Device ID: 00865453000324
• NIH Device Record Key: ef18ac01-265c-4413-b589-11f6e02f03e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StaySure
• Version Model Number: 110114
• Catalog Number: 110114
• Company DUNS: 034186582
• Company Name: Minnesota Medical Technologies Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865453000324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243367

FDA Product Code

• PBP: Rectal Insert

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-31
• Device Publish Date: 2026-03-23

On-Brand Devices [StaySure]

• 00865453000317: Fecal Incontinence Insert, StaySure, 10-Pack, Large
• 00865453000300: Fecal Incontinence Insert, StaySure, 10-Pack, Standard
• 00865453000355: Fecal Incontinence Insert, StaySure, Evaluation Kit
• 00865453000324: Fecal Incontinence Insert, StaySure, Starter Pack