ReActiv8 IPG 5100

GUDID 05391527770015

ReActiv8 Implantable Pulse Generator

MAINSTAY MEDICAL LIMITED

Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator Implantable lumbar neuromuscular electrical stimulation system pulse generator
Primary Device ID05391527770015
NIH Device Record Keye318cb7d-6145-4530-a634-987d8381d0ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameReActiv8 IPG
Version Model Number7M5100-002
Catalog Number5100
Company DUNS985519015
Company NameMAINSTAY MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS105391527770015 [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 Date2021-02-02
Device Publish Date2021-01-25

Devices Manufactured by MAINSTAY MEDICAL LIMITED

05391527772804 - ReActiv8 Release Tool2024-01-30
05391527770015 - ReActiv8 IPG2021-02-02ReActiv8 Implantable Pulse Generator
05391527770015 - ReActiv8 IPG2021-02-02 ReActiv8 Implantable Pulse Generator
05391527770213 - ReActiv8 Programming Wand2021-02-02 Programming Wand
05391527770411 - ReActiv8 Activator2021-02-02 ReActiv8 Activator (for patient use to initiate ReActiv8 Therapy Delivery)
05391527770626 - ReActiv8 Magnet2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
05391527770633 - ReActiv8 Magnet2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
05391527770817 - ReActiv8 Torque Wrench2021-02-02 Torque Wrench (packaged as a standalone accessory)
05391527772064 - ReActiv8 Stimulation Lead2021-02-02 Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.
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