ENDOCARE, INC.

Address:400, rue Montfort,Montreal Quebec,CA

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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

TempProbe™ - 00810563020113 Catalog Number : CRYO-54-F

Device Description : Endocare™ TempProbe™ Device

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

TempProbe™ - 00810563020120 Catalog Number : CRYO-55-F

Device Description : Endocare™ TempProbe™ Device

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

RenalCryo™ - 00810563020250 Catalog Number : R3.8

Device Description : Endocare™ 3.8mm RenalCryo™ Cryoprobe

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

RenalCryo™ - 00810563020267 Catalog Number : R3.8L

Device Description : Endocare™ 3.8mm Long Shaft RenalCryo™ Cryoprobe

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

N/A - 00810563020342 Catalog Number : CRYO-63

Device Description : Endocare™ Urethral Warming System

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryocare CS™ - 00810563020366 Catalog Number : CRYO-CS-3 Version 4

Device Description : Endocare™ Cryocare CS™ System Version 4

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

Cryocare CS™ - 00810563020373 Catalog Number : CRYO-CS-3 Version 4

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

N/A - 00810563020380 Catalog Number : CRYO-77

Device Description : Endocare™ Urethral Warming Catheter Kit

Device Class : 2

Duns Number: 928955509

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

N/A - 00810563020397 Catalog Number : CRYO-207V

Device Description : Endocare™ Prostate Procedure Probe Pack6 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

Cryocare CS™ - 00810563020410 Catalog Number : CRYO-CS-3 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

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