ReActiv8 IPG 5100

GUDID 05391527770046

ReActiv8 Implantable Pulse Generator

MAINSTAY MEDICAL LIMITED

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID05391527770046
NIH Device Record Key97632cad-731a-48db-905c-929c6e6aadb1
Commercial Distribution StatusIn Commercial Distribution
Brand NameReActiv8 IPG
Version Model Number7M5100-005
Catalog Number5100
Company DUNS985519015
Company NameMAINSTAY MEDICAL LIMITED
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

Customer Support Contacts

Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com
Phone877-702-8488
Emailinfo@mainstay-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105391527770046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-21
Device Publish Date2025-02-13

On-Brand Devices [ReActiv8 IPG]

05391527770015ReActiv8 Implantable Pulse Generator
05391527770046ReActiv8 Implantable Pulse Generator

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.