| 2023-05-25 |
K231169 |
STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
MLR |
Class II |
General Hospital |
| 2023-05-09 |
K223025 |
Tyvek Roll with CI for STERLINK Sterilizer |
FRG |
Class II |
General Hospital |
| 2023-05-09 |
K223023 |
Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
FRC |
Class II |
General Hospital |
| 2023-05-09 |
K223015 |
STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette |
MLR |
Class II |
General Hospital |
| 2023-04-14 |
K220345 |
STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
MLR |
Class II |
General Hospital |
| 2021-10-22 |
K212200 |
STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette |
MLR |
Class II |
General Hospital |
| 2021-10-22 |
K212198 |
Tyvek(R) Roll with CI for STERLINKTM Sterilizer |
FRG |
Class II |
General Hospital |
| 2021-10-22 |
K212193 |
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) |
FRC |
Class II |
General Hospital |