Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

75753B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 24, 2019

Issuing Agency

In GS1

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OFX

Product Code Name

General purpose dental tray

Public Device Record Key

d0f919fb-345e-470b-9cad-3b3441ddb543

Public Version Date

July 26, 2019

Public Version Number

3

DI Record Publish Date

March 01, 2017

Package DI Number

20809160130602

Quantity per Package

25

Contains DI Package

10809160130605

Package Discontinue Date

July 24, 2019

Package Status

Not in Commercial Distribution

Package Type

-