Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

07-PK805

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012168,K012168

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

15cd505f-f09b-4f2d-9b2f-442aa46db730

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

10848340002097

Quantity per Package

5

Contains DI Package

00848340002090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-