Catalog Number

-

Brand Name

AngioSystems Drape

Version/Model Number

3028

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

355c0b7c-9c2b-4f3d-b8a6-ff9ec8d365df

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

June 15, 2016

Package DI Number

00816611020111

Quantity per Package

20

Contains DI Package

00816611020104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-