Catalog Number

EK002

Brand Name

Evie

Version/Model Number

EK002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

01bdbb34-6781-460a-801a-5927dd3de015

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

November 09, 2016

Package DI Number

17290016876021

Quantity per Package

3

Contains DI Package

07290016876024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box