ReActiv8 Magnet 4000

GUDID 05391527770633

ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).

MAINSTAY MEDICAL LIMITED

Implantable stimulator control magnet

• Primary Device ID: 05391527770633
• NIH Device Record Key: 5253d450-26ad-42d4-af50-9941020752c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReActiv8 Magnet
• Version Model Number: 6M4000-004
• Catalog Number: 4000
• Company DUNS: 985519015
• Company Name: MAINSTAY MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391527770633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190021

FDA Product Code

• QLK: Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-02
• Device Publish Date: 2021-01-25

On-Brand Devices [ReActiv8 Magnet]

• 05391527770633: ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
• 05391527770626: ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).