Catalog Number

P429589A

Brand Name

MEDLINE

Version/Model Number

P429589A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

-

FDA Premarket Submission

-

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Public Device Record Key

936aedbc-d466-4ca1-bc3f-804156cd697a

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Package DI Number

40889942436348

Quantity per Package

20

Contains DI Package

10889942436347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE