Medical Action Industries - 2 CLEAR - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

Device Description: 2 CLEAR

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More Product Details

Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

310

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2019

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

K102158

Product Code Details

Product Code

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

9b9641cf-75a5-4d90-9249-26ad040c266d

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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