ENDOCARE, INC.

Address:400, rue Montfort,Montreal Quebec,CA

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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

System, Ablation, Microwave And Accessories (NEY) (5) Unit, Cryosurgical, Accessories (GEH) (5)

Premarket Exempt

Clear

N/A - 00810563020427 Catalog Number : CRYO-204-V

Device Description : Endocare™ Prostate Procedure Probe Pack4 x CVA24006 x CRYO-55-F1 x CRYO-77

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

V-Probe™ - 00810563020489 Catalog Number : CVA2400RA

Device Description : Endocare™ Right-Angle 2.4mm V-Probe™ Cryoprobe

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

PerCryo™ - 00810563020496 Catalog Number : PCS-17RS

Device Description : Endocare™ 1.7mm PerCryo™ Short Cryoprobe

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryocare CS™ - 00810563020502 Catalog Number : CRYO-CS-3 100V Basic

Device Description : Endocare™ Cryocare CS™ System Basic

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryocare CS™ - 00810563020519 Catalog Number : CRYO-CS-3 100V Version 5

Device Description : Endocare™ Cryocare CS™ System Version 5

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

MicroThermX Microwave Ablation System - 00810563020526 Catalog Number : MTX-180-T2

Device Description : MicroThermX Microwave Ablation System - Tabletop Stand

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

MicroThermX Microwave Ablation System - 00810563020533 Catalog Number : MTX-180

Device Description : MicroThermX Microwave Ablation System - Mobile Cart

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

SynchroWave Antenna Kit - 00810563020540 Catalog Number : SW-1420

Device Description : 20cm Long Tip Antenna and Cooling Circuit

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

SynchroWave Antenna Kit - 00810563020557 Catalog Number : SW-1425

Device Description : 25cm Long Tip Antenna and Cooling Circuit

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

SynchroWave Antenna Kit - 00810563020564 Catalog Number : SWST-1420

Device Description : 20cm Short Tip Antenna and Cooling Circuit

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

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