FDA UDI
In Commercial Distribution
🇺🇸 United States
StaySure
DI: 00865453000331
·
Model: 110104
·
Minnesota Medical Technologies Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- StaySure
- Primary DI
- 00865453000331
- Version / Model
- 110104
- Catalog Number
- 110104
- Company Name
- Minnesota Medical Technologies Corporation
- Labeler DUNS
- 034186582
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2026-03-23
- Public Version
- 1
- Public Version Date
- 2026-03-31
- Public Version Status
- New
- Public Device Record Key
- ac6289cb-f502-48e8-bc9b-6393e1111986
Device Description
Fecal Incontinence Insert, StaySure, 30-Pack, Standard
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PBP | Rectal Insert | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00865453000300 | GS1 | ||||
| Primary | 00865453000331 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243367 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Standard |