Catalog Number

-

Brand Name

DMEK Infusion Sleeve

Version/Model Number

PD500.27

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2020

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"

Yes

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

3b31bdc3-5583-42a2-b322-731894f31b20

Public Version Date

August 17, 2020

Public Version Number

6

DI Record Publish Date

May 15, 2018

Package DI Number

10632307002226

Quantity per Package

5

Contains DI Package

00632307002229

Package Discontinue Date

August 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Box