Medical Action Industries - Moleskin: 12inx5Yd Bge 1 Roll/Bx - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

Device Description: Moleskin: 12inx5Yd Bge 1 Roll/Bx

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More Product Details

Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

58364

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

FMP

Product Code Name

Protector, skin pressure

Device Record Status

Public Device Record Key

35f0b84a-819d-4b56-add3-97f49ede94d3

Public Version Date

July 07, 2020

Public Version Number

3

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