Catalog Number

-

Brand Name

Natural Cycles

Version/Model Number

B

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

DEN170052

Product Code

PYT

Product Code Name

Device, Fertility Diagnostic, Contraceptive, Software Application

Public Device Record Key

73a9b1b6-d2d8-4a13-a628-8fbd028d2139

Public Version Date

March 12, 2019

Public Version Number

1

DI Record Publish Date

March 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-