Medical Action Industries - Sponge: Lap 18x18 W 200/Cs - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

Device Description: Sponge: Lap 18x18 W 200/Cs

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More Product Details

Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

400

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

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Device Record Status

Public Device Record Key

7619ffdd-527c-498c-82b8-ef2611f5664d

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

50809160000074

Quantity per Package

40

Contains DI Package

10809160000076

Package Discontinue Date

-

Package Status

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