Catalog Number

78-2510

Brand Name

Sharpoint

Version/Model Number

78-2510

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

6070ce64-6973-4f6d-a21d-d863bad7b3dc

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 21, 2021

Package DI Number

10848782028945

Quantity per Package

6

Contains DI Package

00848782028948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box