StimQ Freedom-4A Spare Kit Channel B US w/ Receiver

GUDID 00818225020747

StimQ Peripheral Nerve Stimulator System StimQ Freedom-4A Spare Kit Channel B US w/ Receiver

STIMWAVE TECHNOLOGIES INCORPORATED

Analgesic implantable peripheral nerve electrical stimulation system Analgesic implantable peripheral nerve electrical stimulation system
Primary Device ID00818225020747
NIH Device Record Keyecfcc633-9509-4aae-b340-79a59a5c0e4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStimQ Freedom-4A Spare Kit Channel B US w/ Receiver
Version Model NumberFR4A-SPR-B0
Company DUNS078294927
Company NameSTIMWAVE TECHNOLOGIES INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Outer Diameter1.35 Millimeter
Outer Diameter1.35 Millimeter
Outer Diameter1.35 Millimeter
Outer Diameter1.35 Millimeter
Outer Diameter1.35 Millimeter
Outer Diameter1.35 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818225020747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00818225020747]

Ethylene Oxide


[00818225020747]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2018-02-05

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