VR101 Lubricating Intravaginal Ring
J3 Bioscience, Inc.
J3 BIOSCIENCE, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3021574111 | 3021574111 | J3 BIOSCIENCE, INC. | 1 | N | 2026-01-01 | 825 North 300 West, Suite N231 Salt Lake City UT US 84103 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 299895 | 1414145210 | K203377 | VR101 Lubricating Intravaginal Ring | QPD | 2021-05-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QPD | 1 | 2021-05-20 |
PMN#
GUDID#
LivRing(R) - The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to relieve the symptoms of vaginal dryness. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs).Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.
2024-10-07
LivRing(R) - The VR101 Lubricating Intravaginal Ring device is a lubricating intravaginal ring designed to relieve the symptoms of vaginal dryness. VR101 Lubricating Intravaginal Ring is constructed from a hollow biomedical grade hydrophilic polyether urethane (HPU) tube filled with a liquid vaginal lubricating solution comprised of a solution of glycerol (also known as glycerin), water, and sodium chloride. Upon insertion of VR101 Lubricating Intravaginal Ring in the vagina, the lubricating solution in the lumen ring is released through the semi-permeable wall of the tubing into the vagina, moisturizing and lubricating the vaginal mucosa without the use of any hormones or active pharmaceutical ingredients (APIs). Each VR101 Lubricating Intravaginal Ring provides moisturization and lubrication for up to seven (7) days.
2024-10-07