XSTAT 30 Pouch
RevMedx, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009035955 | 3009035955 | REVMEDX, INC. | 1 | N | 2026-01-01 | 25749 SW CANYON CREEK RD STE 300 Wilsonville OR US 97070 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851587006042 | XSTAT - A hemostatic device for severe bleeding. Each device comprises approximately 38 small hemostatic sponges individually marked with an X-shaped radiopaque marker. | 503-218-2172 | info@revmedx.com |
| 00851587006059 | XSTAT - A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker. | 503-218-2172 | info@revmedx.com |
| 00851587006066 | XSTAT - A hemostatic device for severe bleeding. Each device comprises approximately 108 small hemostatic sponges individually marked with an X-shaped radiopaque marker. | 503-218-2172 | info@revmedx.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 163959 | 1311780168 | K210676 | XSTAT 30 Pouch | PGZ | 2021-08-27 |
| 163959 | 2050683109 | K180051 | XSTAT 30, 1-Pack | PGZ | 2018-05-18 |
| 163959 | 1547476837 | K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | PGZ | 2017-05-01 |
| 163959 | 1126982863 | K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | PGZ | 2016-07-28 |
| 163959 | 1708464342 | K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | PGZ | 2015-12-07 |
| 163959 | 1082268525 | DEN130016 | XSTAT | PGZ | 2014-04-03 |
| 163959 | 1573991466 | ||||
| 163959 | 1617185415 | ||||
| 163959 | 1759918211 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PGZ | 6 | 2021-08-27 |
RevMedx, Inc.
RevMedx, Inc.
RevMedx, Inc.
REVMEDX, INC.
REVMEDX, INC.
2026-02-25
2026-02-25
2016-09-02
2023-01-17
2023-01-17
2019-03-28
2016-09-02
2016-09-02