FDA UDI
In Commercial Distribution
🇺🇸 United States
L300 Go System, Left Thigh Plus
DI: 00815962020153
·
Model: L4P-5001
·
BIONESS INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- L300 Go System, Left Thigh Plus
- Primary DI
- 00815962020153
- Version / Model
- L4P-5001
- Company Name
- BIONESS INC.
- Labeler DUNS
- 182287727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-14
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 634c9ce9-3b28-455c-ac04-7d044539937f
Device Description
L300 Go system with Left Thigh cuff
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, muscle, powered | Physical Medicine | 890.5850 | 2 |
| GZI | STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL | Neurology | 882.5810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35725 | Gait-enhancement electrical stimulation system, external | An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815962020153 | GS1 |
Customer Contacts
- Phone
- +1(800)211-9136
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162407 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 55 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Degrees Celsius