Catalog Number

9004822

Brand Name

Customed

Version/Model Number

9004822

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

f0c2fb52-ef06-4890-8341-807ca9ab01d2

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

January 09, 2019

Package DI Number

10850003355112

Quantity per Package

100

Contains DI Package

00850003355115

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case