FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuspera SNM System
DI: 00850075633074
·
Model: WT-2
·
NeuSpera Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Neuspera SNM System
- Primary DI
- 00850075633074
- Version / Model
- WT-2
- Company Name
- NeuSpera Medical Inc.
- Labeler DUNS
- 033985298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-14
- Public Version
- 1
- Public Version Date
- 2025-11-24
- Public Version Status
- New
- Public Device Record Key
- bc2a5dd8-7b48-40fe-ac30-ce16938e96e8
Device Description
Wireless Transmitter
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | 876.5270 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67518 | Implantable pulse generator external transceiver | A noninvasive, electrically-powered device intended to function as a communication interface between an implantable pulse generator (IPG) [e.g., spinal cord electrical stimulation implantable pulse generator] and an external IPG programmer, to enable a clinician to set and adjust the IPG parameters; it is not intended for use with a hearing implant. It is in the form of a small hand-held unit (e.g., a wand) designed to be placed in proximity to the IPG and the programmer. This device does not have IPG programming/adjustment capabilities [i.e., it is not a programmer]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850075633074 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240031 | 000 |