Duns Number:370696875
Device Description: Fertility Lubricant
Catalog Number
880842
Brand Name
Conceive Plus
Version/Model Number
75ml
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
K131355,K131355,K131355
Product Code
PEB
Product Code Name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Public Device Record Key
53b22596-b970-4719-a28a-9338df82a168
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
29337213008420
Quantity per Package
14
Contains DI Package
19337213008423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |