Catalog Number

8516

Brand Name

NOVO Health Services, LLC

Version/Model Number

8516

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

K920404

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

b019efee-e0b3-488a-b0e1-4ceb9de6742d

Public Version Date

November 01, 2018

Public Version Number

1

DI Record Publish Date

October 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-