BiSurge

GUDID 00877972006619

GENICON, INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 00877972006619
• NIH Device Record Key: ba8d472a-5b16-4a22-a710-4eb8726feddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiSurge
• Version Model Number: 620-163-920
• 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: 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	00877972006619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041968

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: 2017-10-11

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