FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NESS L300 Foot Drop System
DI: 07290110483050
·
Model: LG3-5100
·
BIONESS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NESS L300 Foot Drop System
- Primary DI
- 07290110483050
- Version / Model
- LG3-5100
- Catalog Number
- 501-00158-01
- Company Name
- BIONESS INC.
- Labeler DUNS
- 182287727
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-02
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 1997f382-6f7d-412b-ab0b-5548dfd1ea59
- Distribution End Date
- 2017-09-30
Device Description
Regular L300 System Kit, Left US
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
- Yes
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, muscle, powered | Physical Medicine | 890.5850 | 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 | 07290110483050 | GS1 |
Customer Contacts
- Phone
- +97297907100 ext. 100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122784 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius