Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

79415

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

KDD

Product Code Name

Kit, surgical instrument, disposable

Public Device Record Key

d160e584-4aad-4092-b09f-ac6f1a4ed267

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

June 18, 2019

Package DI Number

20809160243623

Quantity per Package

50

Contains DI Package

10809160243626

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-