FDA UDI
In Commercial Distribution
🇺🇸 United States
Paired VNS
DI: 10810041430066
·
Model: 3000
·
Microtransponder
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paired VNS
- Primary DI
- 10810041430066
- Version / Model
- 3000
- Company Name
- Microtransponder
- Labeler DUNS
- 793502068
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-29
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- 43430ffe-fbb4-4408-ae97-6bb1b1c750c3
Device Description
Lead, 2 mm cuff
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| QPY | Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44041 | Vagus nerve electrical stimulation system lead | An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810041430066 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210007 | 000 |