Catalog Number

-

Brand Name

Ophthalmic Knife

Version/Model Number

OVS6115

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

-

Product Code

HNN

Product Code Name

Knife, Ophthalmic

Public Device Record Key

ee7f0ff4-4f22-42d6-8bcb-a01ce40c6e43

Public Version Date

January 17, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2021

Package DI Number

08903317020308

Quantity per Package

6

Contains DI Package

08903317013690

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-