Catalog Number

-

Brand Name

Sharpoint

Version/Model Number

J8435N

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

f203ee09-12c5-4fe7-bde5-e64cb7fe72e0

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

10848782031303

Quantity per Package

12

Contains DI Package

00848782030309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box