Guidewire 3-Pack

GUDID 00859619004943

Guidewire 3-Pack

STIMWAVE TECHNOLOGIES INCORPORATED

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00859619004943
NIH Device Record Keya17112e3-d11e-4db3-a445-4109444d8757
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuidewire 3-Pack
Version Model NumberMD0630-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

Device Dimensions

Length17.7 Inch
Length17.7 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859619004943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBStimulator, Spinal-Cord, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00859619004943]

Ethylene Oxide


Device Entry Metadata

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

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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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