Primary Device ID | 40859619004026 |
NIH Device Record Key | ff23cd4e-3ef3-41ac-bdcd-45e578e94ac1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Freedom Spinal Cord Stimulator System |
Version Model Number | FRE4-A000 |
Catalog Number | FRE4-A000 |
Company DUNS | 078294927 |
Company Name | STIMWAVE TECHNOLOGIES INCORPORATED |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Length | 45 Centimeter |
Outer Diameter | 1.3 Millimeter |
Length | 45 Centimeter |
Outer Diameter | 1.3 Millimeter |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit |
Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 40859619004026 [Primary] |
GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
Steralize Prior To Use | true |
Device Is Sterile | true |
[40859619004026]
Ethylene Oxide
[40859619004026]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-11 |
00859619004936 | Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel B US |
00859619004929 | Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US |
00859619004912 | Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel A US |
00859619004882 | Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US |
00859619004875 | Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel A US |
00859619004103 | Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel B US |
00859619004097 | Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US |
00859619004042 | Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel A US |
00859619004035 | Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915 |
00859619004028 | Boogieboard Wearable Antenna Assembly 915 |
40859619004026 | Freedom Spinal Cord Stimulator System Freedom-4 SCS Receiver Kit |