Catalog Number

-

Brand Name

innovo Spray

Version/Model Number

18-52-970605

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K780973,K780973,K780973

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

5e6f764b-0281-4c66-b4fe-8c928af7a20d

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

10855683006675

Quantity per Package

12

Contains DI Package

00855683006678

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner