NanoSurge

GUDID 00877972005957

GENICON, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00877972005957
• NIH Device Record Key: 37fed858-b2e6-4e38-853d-398e59cd1e36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoSurge
• Version Model Number: 528-063-910
• Company DUNS: 079805400
• Company Name: GENICON, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972005957 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061417

FDA Product Code

• GEA: Cannula, Surgical, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-05-05

On-Brand Devices [NanoSurge]

• 00877972006251: 520-063-950
• 00877972006237: 520-063-945
• 00877972006213: 520-063-920
• 00877972006190: 520-063-910
• 00877972006015: 528-063-950
• 00877972005995: 528-063-945
• 00877972005971: 528-063-920
• 00877972005957: 528-063-910