FDA UDI
In Commercial Distribution
🇺🇸 United States
Xavant Technology
DI: 06009880396030
·
Model: Nerve mapping cable
·
XAVANT TECHNOLOGY (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Xavant Technology
- Primary DI
- 06009880396030
- Version / Model
- Nerve mapping cable
- Catalog Number
- XT-46003
- Company Name
- XAVANT TECHNOLOGY (PTY) LTD
- Labeler DUNS
- 639571707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-18
- Public Version
- 4
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 11474a9b-3892-4f6a-9b56-4e264dc668ed
Device Description
Nerve mapping cable for NMS460.
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
- No
- 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 | 06009880396030 | GS1 | ||||
| Package | 16009880396037 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 26009880396034 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 36009880396031 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 46009880396038 | GS1 | Box | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161091 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius