Catalog Number

8604

Brand Name

NOVO Health Services, LLC

Version/Model Number

8604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2021

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

K041541

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

d0b75a12-1109-4007-abad-36c9029010e7

Public Version Date

July 15, 2021

Public Version Number

2

DI Record Publish Date

March 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-