FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Science Products
DI: 00851610008326
·
Model: COM-TENS
·
SAUVRE INTERNATIONAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Science Products
- Primary DI
- 00851610008326
- Version / Model
- COM-TENS
- Catalog Number
- COM-TENS
- Company Name
- SAUVRE INTERNATIONAL, LTD.
- Labeler DUNS
- 080557421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-29
- Public Version
- 3
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 5b73e5fe-8c99-47d5-8736-50eda0d82bc3
Device Description
Analog TENS 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
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851610008326 | GS1 | ||||
| Package | 00851610008333 | GS1 | Bag | 1 | In Commercial Distribution | |
| Package | 10851610008330 | GS1 | Box | 100 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071624 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 90 | Millimeter | |
| Width | 65 | Millimeter | |
| Weight | 120 | Gram | |
| Height | 20 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 70 Degrees Celsius