AVID TRUCUSTOM - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

AVID TRUCUSTOM

Version/Model Number

VAMM046-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 2019

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

KDD

Product Code Name

Kit, surgical instrument, disposable

Device Record Status

Public Device Record Key

4688bf80-3f31-4904-a0e0-d2f851f927fa

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

October 12, 2016

Additional Identifiers

Package DI Number

20809160109981

Quantity per Package

50

Contains DI Package

10809160109984

Package Discontinue Date

April 03, 2019

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