Catalog Number

-

Brand Name

Novii

Version/Model Number

107-PT-002-US

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

-

Product Code

OSP

Product Code Name

Uterine Electromyographic Monitor

Public Device Record Key

6998a4ad-98be-462f-9bb6-45667204f55c

Public Version Date

September 25, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

15060433670241

Quantity per Package

1

Contains DI Package

05060433670244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton