Catalog Number

-

Brand Name

Sharpoint

Version/Model Number

78-6810

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

5d5486d0-234c-420d-91ae-a7a1adc6f2c0

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

10848782028976

Quantity per Package

6

Contains DI Package

00848782028979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box