FDA UDI
In Commercial Distribution
🇺🇸 United States
Urgent® PC Neuromodulation System
DI: 08717591240228
·
Model: UPC 200
·
Uroplasty, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Urgent® PC Neuromodulation System
- Primary DI
- 08717591240228
- Version / Model
- UPC 200
- Catalog Number
- UPC 200
- Company Name
- Uroplasty, Inc.
- Labeler DUNS
- 804002665
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d708236f-d2f3-421d-a3ab-d989a6a1e38d
Device Description
Stimulator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NAM | Stimulator,Peripheral Nerve,Non-Implanted,For Pelvic Floor Dysfunction | Gastroenterology, Urology | 876.5310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47028 | Tibial nerve percutaneous incontinence-control electrical stimulation system | An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08717591240228 | GS1 |
Customer Contacts
- Phone
- 866-258-2182
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101847 | 000 |