Simply EZee

GUDID 00877972007395

GENICON, INC.

Tissue extraction bag

• Primary Device ID: 00877972007395
• NIH Device Record Key: 7f73d65f-fbb1-4cf9-a1d2-3e353b02478a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simply EZee
• Version Model Number: 550-000-026
• 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	00877972007395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181791

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-29
• Device Publish Date: 2018-10-29

On-Brand Devices [Simply EZee]

• 00877972007395: 550-000-026
• 00877972007371: 550-000-027
• 00877972007241: 550-000-020