Catalog Number

ART1165

Brand Name

MEDLINE

Version/Model Number

ART1165

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

ea439e9b-4d45-4fb1-8bc2-1b4a8d5098c6

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Package DI Number

00653160354683

Quantity per Package

5

Contains DI Package

10653160354680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE