C2 THERAPEUTICS, 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) (9)

Premarket Exempt

Clear

C2 CryoBalloon - 00854924006187 Catalog Number : FG-1018

Device Description : Foot Pedal

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006248 Catalog Number : FG-1024

Device Description : Pear Catheter Focal

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006262 Catalog Number : FG-1026

Device Description : 90 Pear Catheter

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006279 Catalog Number : FG-1027

Device Description : 180 Pear Catheter

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006286 Catalog Number : FG-1028

Device Description : Focal Standard Catheter 30-mm

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006309 Catalog Number : FG-1030

Device Description : 90 Standard Catheter 30-mm

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon - 00854924006316 Catalog Number : FG-1031

Device Description : 180 Standard Catheter 30-mm

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Full 8 Catheter - 00854924006323 Catalog Number : FG-1032

Device Description : C2 CryoBalloon Full 8 Catheter for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

C2 CryoBalloon Focal Pear Catheter - 00854924006330 Catalog Number : FG-1033

Device Description : C2 CryoBalloon Focal Pear Catheter for C2 CryoBalloon Ablation System

Device Class : 2

Duns Number: 929139249

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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