AmplifEYE

Basic Information

• Brand Name: AmplifEYE
• Primary DI: 00677964074196
• Version / Model: EYE-101
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-13
• Public Version: 6
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: dab41cc4-8af7-4bf9-9f7a-32153650dd8d
• Distribution End Date: 2023-01-13

Device Description

AmplifEYE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60911	Colonic endoscopy cuff	A sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy. It is in the form of a polymer cuff with retractable concentric fingers intended to open and grip the colon during pull back (exturbation) to straighten colonic folds and centralize the endoscope within the lumen; it is not intended to hinder intubation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20677964074190	GS1	Case	120	Not in Commercial Distribution	2023-01-13
Primary	00677964074196	GS1
Package	10677964074193	GS1	Carton	20	Not in Commercial Distribution	2023-01-13

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160846	000