MAI - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

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More Product Details

Catalog Number

-

Brand Name

MAI

Version/Model Number

81574

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OGJ

Product Code Name

Nerve block tray

Device Record Status

Public Device Record Key

a92d42a8-2e28-416c-9341-7f94a4bbb4b3

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Additional Identifiers

Package DI Number

20809160295400

Quantity per Package

20

Contains DI Package

10809160295403

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