CONMED

GUDID 00412786063870

Anti Fog

UNIMAX MEDICAL SYSTEMS INC.

Endoscopic antifog solution

• Primary Device ID: 00412786063870
• NIH Device Record Key: 95bf2940-a42e-4794-8e77-3c68b16089ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONMED
• Version Model Number: CD004
• Company DUNS: 658122465
• Company Name: UNIMAX MEDICAL SYSTEMS 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00412786063870 [Previous]
GS1	04714127860893 [Primary]
GS1	14714127860890 [Package]; Contains: 04714127860893; Package: Box [20 Units]; In Commercial Distribution
GS1	24714127860897 [Package]; Contains: 14714127860890; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111622

FDA Product Code

• OCT: Anti Fog Solution And Accessories, Endoscopy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-17
• Device Publish Date: 2019-12-17

On-Brand Devices [CONMED]

• 20412786063874: Anti Fog
• 20412786063867: Endo pouch
• 20412786063225: Endo pouch
• 20412786063218: Endo pouch
• 20412786063201: Endo pouch
• 20412786063195: Endo pouch
• 20412786063188: Monopolar Scissors
• 20412786063133: Endo pouch
• 20412786063126: Endo pouch
• 20412786063119: Endo pouch
• 20412786063102: Endo pouch
• 20412786063324: Monopolar scissors
• 00412786063863: Endo Pouch
• 00412786063870: Anti Fog
• 00412786063320: Monopolar Scissors
• 00412786063221: Endo Pouch
• 00412786063214: Endo Pouch
• 00412786063207: Endo Pouch
• 00412786063191: Endo Pouch
• 00412786063184: Monopolar Scissors
• 00412786063139: Endo Pouch
• 00412786063122: Endo Pouch
• 00412786063115: Endo Pouch
• 04714127860657: Endo Pouch