Catalog Number

STER129985

Brand Name

Medline Industries, Inc.

Version/Model Number

STER129985

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"

-

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

6587beae-a49e-4846-8afb-f68d4e78f708

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

August 24, 2021

Package DI Number

40193489811378

Quantity per Package

50

Contains DI Package

10193489811377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE