RF Stylet

GUDID 00818225020068

RF Stylet

STIMWAVE TECHNOLOGIES INCORPORATED

Analgesic spinal cord electrical stimulation system
Primary Device ID00818225020068
NIH Device Record Key92d8d7d2-d4ad-47d6-8950-df8de9961d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameRF Stylet
Version Model NumberMD0528-A
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100818225020068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00818225020068]

Ethylene Oxide


[00818225020068]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-26
Device Publish Date2018-10-25

Devices Manufactured by STIMWAVE TECHNOLOGIES INCORPORATED

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00818225021850 - PNS Wearable Accessory L/XL Vertical2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
00818225021867 - PNS Wearable Accessory L/XL Horizontal2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
00818225021874 - PNS Wearable Accessory S/M2023-02-22 Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
00818225022031 - Stimwave Freedom Spinal Cord Stimulation System2023-02-22 Torso Belt Size XS Assembly
00818225022048 - Stimwave Freedom Spinal Cord Stimulation System2023-02-22 Torso Belt Size S Assembly
00818225022055 - Stimwave Freedom Spinal Cord Stimulation System2023-02-22 Torso Belt Size M Assembly
00818225022062 - Stimwave Freedom Spinal Cord Stimulation System2023-02-22 Torso Belt Size L Assembly

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