GeniShield

GUDID 00877972000488

GENICON, INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 00877972000488
• NIH Device Record Key: 12c83797-a373-43ba-b32b-844bf209509b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniShield
• Version Model Number: 100-005-092
• 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	00877972000488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982472

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: 4
• Public Version Date: 2020-01-09
• Device Publish Date: 2017-05-05

On-Brand Devices [GeniShield]

• 00877972003540: 100-105-091
• 00877972002420: 100-112-191
• 00877972002383: 100-110-192
• 00877972002369: 100-110-191
• 00877972002307: 100-105-192
• 00877972002284: 100-105-191
• 00877972002260: 100-010-192
• 00877972000556: 100-012-191
• 00877972000549: 100-012-090
• 00877972000532: 100-010-191
• 00877972000525: 100-010-090
• 00877972000488: 100-005-092
• 00877972000471: 100-005-091
• 00877972000464: 100-005-090
• 00877972000440: 100-005-190
• 00877972000433: 100-005-191
• 00877972000426: 100-005-192