Catalog Number

880845

Brand Name

Conceive Plus

Version/Model Number

8x4g

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131355,K131355,K131355

Product Code

PEB

Product Code Name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Public Device Record Key

3b1dd23b-ced4-49a1-a89b-15ae059f8e3f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 03, 2016

Package DI Number

29337213008451

Quantity per Package

12

Contains DI Package

19337213008454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton