AccuTray - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

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More Product Details

Catalog Number

-

Brand Name

AccuTray

Version/Model Number

5200115

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2020

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

Yes

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

554de64c-6cb2-47b6-a12a-d0cc196327b0

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

February 27, 2020

Additional Identifiers

Package DI Number

20809160279172

Quantity per Package

24

Contains DI Package

10809160279175

Package Discontinue Date

October 07, 2020

Package Status

Not 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