Catalog Number

-

Brand Name

Chopper Koch 1.4mm

Version/Model Number

41-4008

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HND

Product Code Name

Spatula, Ophthalmic

Public Device Record Key

16b0a16c-3df2-4528-bfb2-6cb8b2b3ae2a

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

05060745554805

Quantity per Package

10

Contains DI Package

05060745554799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-