Catalog Number

129029

Brand Name

NOVO Health Services, LLC

Version/Model Number

129029

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 02, 2020

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

-

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

K080796

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

172315f7-1d96-48ba-b067-700f4adb5dca

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-