Primary Device ID | 00810188050052 |
NIH Device Record Key | 3b12af31-4bb4-4c1c-80bc-df542d6ab384 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | L360 Thigh System |
Version Model Number | L4T-6000 |
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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
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 | |
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 |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810188050052 [Primary] |
GS1 | 00815962020399 [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 | 2025-07-28 |
Device Publish Date | 2025-07-18 |
00810188050069 | L360 Thigh System Kit, Left |
00810188050052 | L360 Thigh System Kit, Right |