Catalog Number

-

Brand Name

#LubeLife – Trying to Conceive (TTC) – 2oz

Version/Model Number

42013

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

K212705,K212705

Product Code

PEB

Product Code Name

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

Public Device Record Key

b9158f93-e483-41ad-a6b6-04e1f5ff2448

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Package DI Number

10796494001636

Quantity per Package

72

Contains DI Package

00796494001639

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-