FDA UDI
In Commercial Distribution
🇺🇸 United States
Xavant Technology
DI: 06009880396085
·
Model: Nerve Locate 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
- 06009880396085
- Version / Model
- Nerve Locate Cable
- Catalog Number
- XT-41003
- Company Name
- XAVANT TECHNOLOGY (PTY) LTD
- Labeler DUNS
- 639571707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2b6e8882-a32b-43ae-96fc-17e8bbf27ca2
Device Description
This cable is used to activate the Nerve Locating mode on the STIMPOD. The red (anode) connector is designed to clip on to a standard ECG electrode. The 2mm needle connector will accommodate various makes of needles.
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
- 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 |
|---|---|---|---|---|
| BXN | Stimulator, Nerve, Battery-Powered | Anesthesiology | 868.2775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35729 | Diagnostic peripheral nerve electrical stimulation system | An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009880396085 | GS1 | ||||
| Package | 16009880396082 | GS1 | Box | 1 | In Commercial Distribution | |
| Package | 26009880396089 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 36009880396086 | GS1 | Box | 2 | In Commercial Distribution | |
| Package | 46009880396083 | GS1 | Box | 2 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102084 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius