ARRINEX, INC.

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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) (5)

Premarket Exempt

Clear

ClariFix - 00868438000203 Catalog Number :

Device Description : Cryotherapy Device

Device Class : 2

Duns Number: 079807364

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

ClariFix - 00868438000210 Catalog Number :

Device Description : Cryogen Canister, 21ml

Device Class : 2

Duns Number: 079807364

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

ClariFix - 00868438000227 Catalog Number :

Device Description : Cryogen Canister, 10ml

Device Class : 2

Duns Number: 079807364

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

ClariFix - 00868438000234 Catalog Number : CFX-1000

Device Description : Cryotherapy System

Device Class : 2

Duns Number: 079807364

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

ClariFix - 00868438000258 Catalog Number : CFX-1002

Device Description : Cryogen Canister

Device Class : 2

Duns Number: 079807364

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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