Catalog Number

-

Brand Name

Novii

Version/Model Number

107-PT-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

0b662774-c719-4a46-a49a-aa430b8755ac

Public Version Date

September 25, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

15060433670050

Quantity per Package

1

Contains DI Package

05060433670053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box