Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

56443B

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDC

Product Code Name

INSTRUMENT, SURGICAL, DISPOSABLE

Public Device Record Key

69082c55-a671-4933-a751-83e38760a8ce

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

December 06, 2019

Package DI Number

20809160273743

Quantity per Package

20

Contains DI Package

10809160273746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-