ReActiv8 Release Tool

GUDID 05391527772804

MAINSTAY MEDICAL LIMITED

Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use Orthopaedic implant inserter/extractor, single-use

• Primary Device ID: 05391527772804
• NIH Device Record Key: 459f0e8c-a3e2-4119-9a20-f18ae1618162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReActiv8 Release Tool
• Version Model Number: EXT1
• Company DUNS: 985519015
• Company Name: MAINSTAY MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• Donation Id Number: true
• 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	05391527772804 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

[05391527772804]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

Devices Manufactured by MAINSTAY MEDICAL LIMITED

• 05391527772804 - ReActiv8 Release Tool: 2024-01-30
• 05391527772804 - ReActiv8 Release Tool: 2024-01-30
• 05391527770015 - ReActiv8 IPG: 2021-02-02 ReActiv8 Implantable Pulse Generator
• 05391527770213 - ReActiv8 Programming Wand: 2021-02-02 Programming Wand
• 05391527770411 - ReActiv8 Activator: 2021-02-02 ReActiv8 Activator (for patient use to initiate ReActiv8 Therapy Delivery)
• 05391527770626 - ReActiv8 Magnet: 2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
• 05391527770633 - ReActiv8 Magnet: 2021-02-02 ReActiv8 Magnet (for use in starting or stopping therapy dependent upon IPG programming).
• 05391527770817 - ReActiv8 Torque Wrench: 2021-02-02 Torque Wrench (packaged as a standalone accessory)
• 05391527772064 - ReActiv8 Stimulation Lead: 2021-02-02 Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.