Catalog Number

9004819

Brand Name

Customed

Version/Model Number

9004819

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)

-

Over the Counter (OTC)

Yes

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

6add58b0-29e7-49b5-bdde-44d818ab998a

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

10850003355075

Quantity per Package

80

Contains DI Package

00850003355078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case