Catalog Number

82-2263G

Brand Name

Clear Corneal Knife 2.2MM ANG

Version/Model Number

82-2263G

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

K822112,K822112

Product Code

HNN

Product Code Name

Knife, ophthalmic

Public Device Record Key

9357f055-25e8-432e-aac5-78130c1bf0ac

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

10848782004888

Quantity per Package

5

Contains DI Package

00848782004881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box