Catalog Number

-

Brand Name

None

Version/Model Number

470341

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

40e7c0cd-75be-4d6a-bb8b-f65ca5db6e95

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

July 08, 2016

Package DI Number

10886874112479

Quantity per Package

20

Contains DI Package

00886874112472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX