Freedom Spinal Cord Stimulator System FRE4-A000

GUDID 40859619004026

Freedom Spinal Cord Stimulator System Freedom-4 SCS Receiver Kit

STIMWAVE TECHNOLOGIES INCORPORATED

Analgesic spinal cord electrical stimulation system
Primary Device ID40859619004026
NIH Device Record Keyff23cd4e-3ef3-41ac-bdcd-45e578e94ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreedom Spinal Cord Stimulator System
Version Model NumberFRE4-A000
Catalog NumberFRE4-A000
Company DUNS078294927
Company NameSTIMWAVE TECHNOLOGIES INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length45 Centimeter
Outer Diameter1.3 Millimeter
Length45 Centimeter
Outer Diameter1.3 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS140859619004026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[40859619004026]

Ethylene Oxide


[40859619004026]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-11

On-Brand Devices [Freedom Spinal Cord Stimulator System]

00859619004936Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel B US
00859619004929Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US
00859619004912Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel A US
00859619004882Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel B US
00859619004875Freedom Spinal Cord Stimulator System Freedom-8A Receiver Kit Channel A US
00859619004103Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel B US
00859619004097Freedom Spinal Cord Stimulator System Freedom-4A Trial Kit Channel A US
00859619004042Freedom Spinal Cord Stimulator System Freedom-4A Receiver Kit Channel A US
00859619004035Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915
00859619004028Boogieboard Wearable Antenna Assembly 915
40859619004026Freedom Spinal Cord Stimulator System Freedom-4 SCS Receiver Kit

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