Paired VNS

GUDID 10810041430080

Lead, 3 mm cuff

Microtransponder

Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead Vagus nerve electrical stimulation system lead
Primary Device ID10810041430080
NIH Device Record Keyb0525b98-27ea-4e4a-a3c2-40b29b34aa0e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePaired VNS
Version Model Number3000
Company DUNS793502068
Company NameMicrotransponder
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
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 Identifiers

Device Issuing AgencyDevice ID
GS110810041430080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [Paired VNS]

10810041430141Wireless Transmitter
10810041430042Wireless Transmitter
10810041430080Lead, 3 mm cuff
10810041430066Lead, 2 mm cuff

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.