PNS Wearable Accessory L/XL Vertical 00-52002

GUDID 00818225021850

Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.

STIMWAVE TECHNOLOGIES INCORPORATED

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Primary Device ID00818225021850
NIH Device Record Key813cfd6a-3e04-4d2d-a975-25c1af0a8896
Commercial Distribution StatusIn Commercial Distribution
Brand NamePNS Wearable Accessory L/XL Vertical
Version Model Number00-52002
Catalog Number00-52002
Company DUNS078294927
Company NameSTIMWAVE TECHNOLOGIES INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100818225021850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

Devices Manufactured by STIMWAVE TECHNOLOGIES INCORPORATED

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00818225021850 - PNS Wearable Accessory L/XL Vertical2023-02-22Externally worn transmitter for the Wearable Antenna Assembly (WAA) to power the device.
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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