Catalog Number

-

Brand Name

AmplifEYE

Version/Model Number

EYE-102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160846,K160846,K160846

Product Code

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Public Device Record Key

058417a0-02f3-417f-a016-d09b4d2663cb

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

February 13, 2018

Package DI Number

20677964074206

Quantity per Package

120

Contains DI Package

00677964074202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case