Catalog Number

5147

Brand Name

N/A

Version/Model Number

N/A

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

-

Product Code

KYG

Product Code Name

Device, Irrigation, Ocular Surgery

Public Device Record Key

8136620b-4123-45d7-930e-7bb9b047a9aa

Public Version Date

September 24, 2018

Public Version Number

2

DI Record Publish Date

April 04, 2018

Package DI Number

30818255010535

Quantity per Package

10

Contains DI Package

10818255010531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton