FDA UDI
In Commercial Distribution
🇺🇸 United States
Urgent® PC Neuromodulation System
DI: 08717591240167
·
Model: UPC 250
·
Uroplasty, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Urgent® PC Neuromodulation System
- Primary DI
- 08717591240167
- Version / Model
- UPC 250
- Catalog Number
- UPC 250
- 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
- e879fecd-5afd-402f-80d1-4000ccfd84c8
Device Description
Lead Set
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 47029 | Tibial nerve percutaneous incontinence-control electrical stimulation system electrode set | A collection of devices designed to be used with a dedicated nonimplantable pulse generator for the delivery of electrical stimuli to the sacral nerve, via percutaneous tibial nerve stimulation (PTNS), to treat urinary and/or faecal incontinence. It typically 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, leads and connectors which are connected to the pulse generator. It conducts an electrical pulse that travels to the sacral nerve plexus via the tibial nerve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08717591240174 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 08717591240167 | GS1 |
Customer Contacts
- Phone
- 866-258-2182
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101847 | 000 |