Csa Medical, Inc.

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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

truFreeze - 00857068006006 Catalog Number : CC3-01

Device Description : truFreeze Console

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006013 Catalog Number : C08407030501

Device Description : Passive Venting Catheter

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006020 Catalog Number : C08407030500

Device Description : Active Venting Catheter

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006037 Catalog Number : ACCCC3CDT05

Device Description : Active Venting Cryo Decompression Tube

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006044 Catalog Number : C08407030500

Device Description : Active Venting Spray Kit5 Active Venting Cryo Decompression Tube5 Active Venting Catheter

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006051 Catalog Number : ACC-CDT04

Device Description : 16 Fr. Active Venting Cryo Decompression Tube

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006068 Catalog Number : CD6-001

Device Description : 16 Fr. Active Venting Kit 5 16 Fr. Active Venting Cryo Decompression Tube 5 Acti 16 Fr. Active Venting Kit 5 16 Fr. Active Venting Cryo Decompression Tube 5 Active Venting Catheter

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006075 Catalog Number : 20-00181

Device Description : 16 Fr. Active Venting Cryo Decompression Tube (Low Durometer)

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006082 Catalog Number : 20-00180

Device Description : 16 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low 16 Fr Active Venting Kit. 5 - 16 Fr Active Venting Cryo Decompression Tube (Low Durometer)5 - Active Venting Catheter

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

truFreeze - 00857068006099 Catalog Number : 20-00177

Device Description : Rapid Av Active Venting Spray Kit - 5 Rapid AV Catheters, 5 Active Venting 16 Fr LD CDT

Device Class : 2

Duns Number: 621229413

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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