Catalog Number

ASK-00002-1A

Brand Name

ARROW

Version/Model Number

IPN032672

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

ebe14456-e19d-4591-b094-2385ad95b82b

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

30801902098208

Quantity per Package

20

Contains DI Package

00801902098207

Package Discontinue Date

March 21, 2018

Package Status

Not in Commercial Distribution

Package Type

Case