BiSurge

GUDID 00877972006312

GENICON, INC.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00877972006312
• NIH Device Record Key: 8162d7a2-7f3f-428e-9a8e-70a682d7cfcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiSurge
• Version Model Number: 633-105-920
• 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: false
• 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	00877972006312 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041968

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-05

On-Brand Devices [BiSurge]

• 00877972006671: 628-163-950
• 00877972006657: 628-163-920
• 00877972006633: 620-163-950
• 00877972006619: 620-163-920
• 00877972006336: 633-105-950
• 00877972006312: 633-105-920
• 00877972006299: 633-005-950
• 00877972006275: 633-005-920