Catalog Number

-

Brand Name

Angiosystems Drape

Version/Model Number

3217NS

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

16cd57ad-ca28-467e-97ef-1c1a7ab8b448

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-