H & O Equipments SA

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Unit, Cryosurgical, Accessories (GEH) (10)

Premarket Exempt

Clear

Freezpen® - 15407008483309 Catalog Number : CL-FPU-18

Device Class : 2

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Freezpen® - 15407008483507 Catalog Number : CL-FPU-35

Device Class : 2

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

Freezpen® - 15407008484009 Catalog Number : CL-N2O-8G-BOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 15

Freezpen® - 15407008484108 Catalog Number : CL-N2O-8G-UNBOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 21

Freezpen® - 15407008484207 Catalog Number : CL-N2O-16G-BOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 6

Freezpen® - 15407008484306 Catalog Number : CL-N2O-16G-UNBOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 12

Freezpen® - 15407008484504 Catalog Number : CL-N2O-35G-UBOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 6

Accurett® - 15407008486003 Catalog Number : S-CO2-8G-BOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 24

Accurett® - 15407008486102 Catalog Number : S-CO2-16G-BOX

Device Class :

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 6

Freezpen - B386CLFP000 Catalog Number : CL-FP-00

Device Class : 2

Duns Number: 370212933

Premarket Exempt : No

Product Code : GEH

Prescription Use : No

Device Count : 1

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