Catalog Number

514000

Brand Name

NOVO Health Services, LLC

Version/Model Number

514000

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

K031933

Product Code

FRL

Product Code Name

Fiber, Medical, Absorbent

Public Device Record Key

ae43b374-43e6-4f62-ba3c-1dcc027c1b6c

Public Version Date

April 07, 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

-