Edge

GUDID 00852087007577

INFINIUM MEDICAL, INC.

Electrosurgical system

• Primary Device ID: 00852087007577
• NIH Device Record Key: 3f1715e2-9772-4e98-b45d-b2bf3c0d1c33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge
• Version Model Number: R80
• Company DUNS: 037504771
• Company Name: INFINIUM MEDICAL, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852087007577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220138

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [Edge]

• 00852087007607: 400
• 00852087007591: 200
• 00852087007584: 160
• 00852087007577: R80