FDA UDI
In Commercial Distribution
🇺🇸 United States
PNS Wearable Accessory L/XL Vertical
DI: 00818225021850
·
Model: 00-52002
·
STIMWAVE TECHNOLOGIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PNS Wearable Accessory L/XL Vertical
- Primary DI
- 00818225021850
- Version / Model
- 00-52002
- Catalog Number
- 00-52002
- Company Name
- STIMWAVE TECHNOLOGIES INCORPORATED
- Labeler DUNS
- 078294927
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 813cfd6a-3e04-4d2d-a975-25c1af0a8896
Device Description
Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
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
- 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
- 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 |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37685 | Personal device holder, reusable | A portable device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, or clothing, or as a trolley with wheels. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818225021850 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182720 | 000 |