Catalog Number

12-1264

Brand Name

CORNEAL TREPHINE BLADE

Version/Model Number

12-1264

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

-

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

HRH

Product Code Name

Trephine, manual, ophthalmic

Public Device Record Key

c3b6acf3-238a-4ade-8390-610ebad5aef7

Public Version Date

October 11, 2019

Public Version Number

2

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-