Catalog Number

-

Brand Name

None

Version/Model Number

470473

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)

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

3e631bb4-5e2b-4162-9a8f-c8a9a706a34e

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

June 05, 2017

Package DI Number

30886874115146

Quantity per Package

6

Contains DI Package

10886874115142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE