Medical Action Industries - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

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More Product Details

Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

235

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

5b033c7a-7398-43aa-a7ee-81f3372a5d50

Public Version Date

September 10, 2020

Public Version Number

5

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

30809160004115

Quantity per Package

8

Contains DI Package

20809160004118

Package Discontinue Date

September 09, 2020

Package Status

Not in Commercial Distribution

Package Type

-

"MEDICAL ACTION INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 548
2 A medical device with a moderate to high risk that requires special controls. 2798
U Unclassified 1