Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

LT-9590MAI

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 11, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K020304

Product Code

FTA

Product Code Name

Light, surgical, accessories

Public Device Record Key

b9dd4754-57a7-4008-8d51-bf23dbf80f1a

Public Version Date

November 12, 2021

Public Version Number

5

DI Record Publish Date

August 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-