Catalog Number

-

Brand Name

AngioSystems Drape

Version/Model Number

RS1000

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

06cfc959-f957-4c89-832a-ae97ee04e0b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2016

Package DI Number

00816611021958

Quantity per Package

20

Contains DI Package

00816611021934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-