Catalog Number

-

Brand Name

AngioSystems Drape

Version/Model Number

3024-31

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

K843260,K843260

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

455c6f19-c4ba-4664-89da-46f6caa81568

Public Version Date

June 01, 2022

Public Version Number

1

DI Record Publish Date

May 24, 2022

Package DI Number

00816611025802

Quantity per Package

125

Contains DI Package

00816611025796

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case