Primary Device ID | 00810188050595 |
NIH Device Record Key | f0b7df45-6d93-4982-92ca-e261802d121c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | L300 Go System |
Version Model Number | LG4-SW01 |
Company DUNS | 119378513 |
Company Name | Bioness Medical, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com | |
Phone | +1(800)211-9136 |
info@bionessmedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810188050595 [Primary] |
GS1 | 00815962020061 [Previous] |
GZI | Stimulator, Neuromuscular, External Functional |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-07-25 |
Device Publish Date | 2025-07-17 |
00810188050595 | Clinician Programmer Software for L300 Go System |
00810188050342 | Hydrogel Electrode Set |
00810188050335 | Small Quick Fit Electrodes - B |
00810188050328 | Small Quick Fit Electrodes - A |
00810188050311 | Small Hydrogel Electrodes, 36mm |
00810188050304 | Small Round Cloth Electrodes, 36mm |
00810188050298 | Round Cloth Electrodes, 45mm |
00810188050281 | Quick Fit Electrode, Left |
00810188050267 | Steering Cloth Electrode, Left |
00810188050250 | Steering Cloth Electrode, Right |
00810188050243 | Thigh Cloth Electrode Set, Offset |
00810188050236 | Thigh Cloth Electrode Set, Centered |
00810188050144 | L300 Go System, Left Thigh Stand-Alone |
00810188050137 | L300 Go System, Right Thigh Stand-Alone |
00810188050113 | L300 Go System, Right Thigh Plus |
00810188050106 | L300 Go System, Left Small Lower |
00810188050090 | L300 Go System, Right Small Lower |
00810188050076 | L300 Go System, Right Lower |