Catalog Number

8050B

Brand Name

NOVO Health Services, LLC

Version/Model Number

8050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 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

35d0e6d9-0377-4af0-8c81-7de9a0551ece

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-