GeniPort

GUDID 00877972000495

GENICON, INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 00877972000495
• NIH Device Record Key: c72c94a6-5847-42fd-8441-83959f6cef27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniPort
• Version Model Number: 100-005-000
• 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	00877972000495 [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 [GeniPort]

• 00877972003601: 100-105-102
• 00877972003588: 100-105-101
• 00877972003526: 100-105-002
• 00877972003502: 100-105-001
• 00877972001874: 100-005-102
• 00877972001867: 100-005-101
• 00877972001850: 100-005-100
• 00877972000518: 100-005-002
• 00877972000501: 100-005-001
• 00877972000495: 100-005-000