Catalog Number

-

Brand Name

Pre-Seed™ Personal Lubricant Fertility Friendly

Version/Model Number

00855114000992

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072741

Product Code

PEB

Product Code Name

Lubricant, personal, gamete, fertilization, and embryo compatible

Public Device Record Key

02e0a16a-5cbb-4bbc-a2c8-1d53a5a001a8

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

March 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-