Catalog Number

9071

Brand Name

Steri-Drape™

Version/Model Number

9071

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)

-

Over the Counter (OTC)

Yes

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

f1f7ddba-4df0-4a26-8e2a-712c7ca5875f

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

50707387581577

Quantity per Package

4

Contains DI Package

30707387581573

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX