Catalog Number

-

Brand Name

AngioSystems Drape

Version/Model Number

3528

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

90f8bb65-39f3-45c2-9a6c-3a723bb8c700

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

April 25, 2018

Package DI Number

00816611022818

Quantity per Package

20

Contains DI Package

00816611022801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-