Cannula

GUDID 00877972003687

GENICON, INC.

Laparoscopic access cannula, single-use

• Primary Device ID: 00877972003687
• NIH Device Record Key: 8f2d6c74-e8a2-4029-9f74-380a8e8a9594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannula
• Version Model Number: 100-110-201
• 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	00877972003687 [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 [Cannula]

• 00877972006398: 100-005-921
• 00877972003724: 100-115-201
• 00877972003700: 100-112-201
• 00877972003687: 100-110-201
• 00877972003663: 100-108-911
• 00877972003649: 100-105-921
• 00877972003625: 100-105-901
• 00877972002444: 100-115-001
• 00877972002406: 100-112-001
• 00877972002345: 100-110-001
• 00877972002321: 100-105-911
• 00877972000686: 100-012-001
• 00877972000679: 100-010-001
• 00877972000662: 100-005-911
• 00877972000655: 100-005-901