Duns Number:049583329
Device Description: Vaginal applicator, single-use: A device designed to apply medication to the vagina. It is Vaginal applicator, single-use: A device designed to apply medication to the vagina. It is typically a simple rod, blade, spatula, or paddle. This is a single-use device.
Catalog Number
RIP-01
Brand Name
Ripelicator
Version/Model Number
RIP-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 21, 2026
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HGD
Product Code Name
Applicator, Vaginal
Public Device Record Key
8f4da95d-8d8b-44d0-bc24-2fb3bb873a44
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
Package DI Number
00860004725114
Quantity per Package
10
Contains DI Package
00860004725107
Package Discontinue Date
July 21, 2026
Package Status
In Commercial Distribution
Package Type
Pouch/Carton