Catalog Number

-

Brand Name

DMEK/DSAEK Forceps

Version/Model Number

PD427.00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 2018

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

-

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

HNR

Product Code Name

Forceps, Ophthalmic

Public Device Record Key

167a2fdd-74a9-4166-8229-50a1dc17ce11

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

March 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-