Duns Number:790780258
Device Description: Astroglide TTC is a personal lubricant for penile and/or vaginal application, intended to Astroglide TTC is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. Astroglide TTC comes in 8 individually wrapped 5 mL pre-filled single use applicators. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Catalog Number
-
Brand Name
Astroglide TTC - Trying to Conceive
Version/Model Number
015594011226
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
K141132
Product Code
PEB
Product Code Name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Public Device Record Key
a0d91872-f613-4f34-94fc-38a6476071a1
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
September 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |