Medical Action Industries - Foam: Pouch 10 Unit w/Loop 50/cs - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

Device Description: Foam: Pouch 10 Unit w/Loop 50/cs

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More Product Details

Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

6810

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)

-

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

00c8b954-1044-476a-90fe-510080d2255f

Public Version Date

February 21, 2019

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