The Q-GUIDE™ Electrode Insertion Tool

GUDID 00802526569401

Electrode Insertion Tool

CAMERON HEALTH, INC.

Surgical torque wrench, reusable

• Primary Device ID: 00802526569401
• NIH Device Record Key: f21154ce-69d0-4c22-bec2-18e5ac30d355
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Q-GUIDE™ Electrode Insertion Tool
• Version Model Number: 4710
• Company DUNS: 017134557
• Company Name: CAMERON HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• 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	00802526569401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110042

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

On-Brand Devices [The Q-GUIDE™ Electrode Insertion Tool]

• 00802526569401: Electrode Insertion Tool
• 00802526531019: Electrode Insertion Tool