AmplifEYE

GUDID 20677964074190

MEDIVATORS INC.

Colonic endoscopy cuff

• Primary Device ID: 20677964074190
• NIH Device Record Key: dab41cc4-8af7-4bf9-9f7a-32153650dd8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmplifEYE
• Version Model Number: EYE-101
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964074196 [Primary]
GS1	10677964074193 [Package]; Contains: 00677964074196; Package: Carton [20 Units]; In Commercial Distribution
GS1	20677964074190 [Package]; Contains: 00677964074196; Package: Case [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160846

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

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: 2018-03-29
• Device Publish Date: 2018-02-13

On-Brand Devices [AmplifEYE]

• 20677964074206: EYE-102
• 20677964074190: EYE-101