Catalog Number

-

Brand Name

Sterile Drape

Version/Model Number

13-055

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)

-

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

b6864e17-7a63-4995-8637-4ac837863223

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Package DI Number

10369771002222

Quantity per Package

50

Contains DI Package

00369771002225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner