FDA UDI
In Commercial Distribution
🇺🇸 United States
BIONESS
DI: 06009880396191
·
Model: STIMPOD ST2-3100 Stimulation Adapter Cable
·
XAVANT TECHNOLOGY (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BIONESS
- Primary DI
- 06009880396191
- Version / Model
- STIMPOD ST2-3100 Stimulation Adapter Cable
- Catalog Number
- ST2-3100
- Company Name
- XAVANT TECHNOLOGY (PTY) LTD
- Labeler DUNS
- 639571707
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-17
- Public Version
- 1
- Public Version Date
- 2025-02-25
- Public Version Status
- New
- Public Device Record Key
- 02ac0fe0-b3ab-4355-9b20-f930d029d778
Device Description
The adapter cable is connected to the ST2-3000 nerve stimulation device for deploying electrical stimulations .
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 |
|---|---|---|---|---|
| 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 | 06009880396191 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140853 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity