FDA UDI
In Commercial Distribution
🇺🇸 United States
L300 Go System
DI: 00810188050250
·
Model: SCE-1000
·
Bioness Medical, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- L300 Go System
- Primary DI
- 00810188050250
- Version / Model
- SCE-1000
- Company Name
- Bioness Medical, Inc.
- Labeler DUNS
- 119378513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-17
- Public Version
- 1
- Public Version Date
- 2025-07-25
- Public Version Status
- New
- Public Device Record Key
- d6632d07-2614-4304-85db-39210f198df9
Device Description
Steering Cloth Electrode, Right
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 |
|---|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | Neurology | 882.5810 | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65318 | Transcutaneous electrical stimulation electrode, reusable | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810188050250 | GS1 | ||||
| Previous | 00815962020429 | GS1 |
Customer Contacts
- Phone
- +1(800)211-9136
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190285 | 000 |