Catalog Number

-

Brand Name

Patient Drape/ Clear View Drape

Version/Model Number

O-CVD-A1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003670,K003670

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

3437d175-f247-4b03-a5d5-bbf5362ae8d3

Public Version Date

May 17, 2022

Public Version Number

1

DI Record Publish Date

May 09, 2022

Package DI Number

10848340010498

Quantity per Package

10

Contains DI Package

00848340010491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-