Catalog Number

-

Brand Name

OvuSense

Version/Model Number

M300

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LHD

Product Code Name

Device, Fertility Diagnostic, Proceptive

Public Device Record Key

e0b6196e-7178-4c7f-abe9-fab219e6b9e7

Public Version Date

March 17, 2021

Public Version Number

3

DI Record Publish Date

December 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-