Conceive Plus - Fertility Lubricant - Sasmar Pharmaceuticals SPRL

Duns Number:370696875

Device Description: Fertility Lubricant

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More Product Details

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

Product Characteristics

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 Details

Product Code

PEB

Product Code Name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Device Record Status

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

Additional Identifiers

Package DI Number

29337213008420

Quantity per Package

14

Contains DI Package

19337213008423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton

"SASMAR PHARMACEUTICALS SPRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15