FDA.reportPublic FDA data

StaySure

Primary DI
00865453000355
Brand
StaySure
Company
Minnesota Medical Technologies Corporation
Model
110115
Catalog number
110115
Device description
Fecal Incontinence Insert, StaySure, Evaluation Kit
Published
2026-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBPRectal Insert

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBPRectal InsertGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243367000Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)Minnesota Medical Technologies2025-07-22PBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865453000355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865453000355008654530003558654530003550865453000355

GMDN Terms#

Term, Definition table
TermDefinition
Anal plug, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034186582
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865453000331StaySure1101041101042026-03-23
00865453000348StaySure1101061101062026-03-23
00865453000362StaySure1101031101032026-03-23
00865453000379StaySure1101051101052026-03-23
00865453000324StaySure1101141101142026-03-23
00865453000300StaySure1101031101032026-03-23
00865453000317StaySure1101051101052026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00865453000331StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000348StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000362StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000379StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000324StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000300StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00865453000317StaySureMinnesota Medical Technologies CorporationPBP2026-03-23
00861680000458Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000465Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000472Navina InsertsRENEW MEDICAL INCPBP2019-01-18
00861680000403Renew InsertsRENEW MEDICAL INCPBP2017-10-01
00861680000410Renew InsertsRENEW MEDICAL INCPBP2017-10-01
00861680000427Renew InsertsRENEW MEDICAL INCPBP2017-10-01
00867476000022Renew InsertsRENEW MEDICAL INCPBP2016-09-16
00867476000039Renew InsertsRENEW MEDICAL INCPBP2016-09-16
00867476000046Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000029Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000036Renew InsertsRENEW MEDICAL INCPBP2016-09-16
10867476000043Renew InsertsRENEW MEDICAL INCPBP2016-09-16