Catalog Number

1578B

Brand Name

NOVO Health Services, LLC

Version/Model Number

1578

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

-

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

K061491,K080723,K982694

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

f82096d4-9ea9-4b44-87ca-666f9ff16ba8

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-