Catalog Number

-

Brand Name

DMEK/DSAEK Infusion Sleeve

Version/Model Number

PD500.27

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"

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

5127b18b-7a74-4b03-aff7-e681825536e4

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

October 18, 2018

Package DI Number

10632307002240

Quantity per Package

5

Contains DI Package

00632307002243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box