FDA UDI
In Commercial Distribution
🇺🇸 United States
Verify™
DI: 00763000879280
·
Model: 353101
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Verify™
- Primary DI
- 00763000879280
- Version / Model
- 353101
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-27
- Public Version
- 4
- Public Version Date
- 2026-01-23
- Public Version Status
- Update
- Public Device Record Key
- 1b81de41-08fd-4068-97a5-af8f6fcc4581
Device Description
ENS 353101 VERIFY ISTM US RFB EMAN
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QON | Implanted electrical device intended for treatment of fecal incontinence | Gastroenterology, Urology | 876.5270 | 3 |
| EZW | Stimulator, electrical, implantable, for incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61392 | Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator | A portable, external battery-powered component of a sacral plexus percutaneous incontinence-control electrical stimulation system, intended to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via percutaneous electrodes (not included). It may be self-controlled or controlled by a separate external programmer. It is typically used during a trial period (<30days) to validate the therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000879280 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P080025 | 282 |
| P970004 | 387 |