COOL RENEWAL, LLC

Address:2515 Eugenia Ave Ste 103,Nashville,TN,37211,US

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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) (4)

Premarket Exempt

Clear

COOL RENEWAL - 00860441000409 Catalog Number : CR-K

Device Description : COOL RENEWAL 340mL REUSABLE TREATMENT KIT WITH APPLICATORS & ACCESSORIES

Device Class : 2

Duns Number: 079489305

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

COOL RENEWAL - 00860441000416 Catalog Number : CR-K1

Device Description : COOL RENEWAL 170mL REUSABLE TREATMENT KIT WITH APPLICATORS & ACCESSORIES

Device Class : 2

Duns Number: 079489305

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

COOL RENEWAL - 00860441000423 Catalog Number : CR-RC1

Device Description : COOL RENEWAL SINGLE REPLACEMENT CANISTER- 170mL

Device Class : 2

Duns Number: 079489305

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

COOL RENEWAL - 00860441000430 Catalog Number : CR-RC

Device Description : COOL RENEWAL TWIN PACK REPLACEMENT CANISTERS- 340mL

Device Class : 2

Duns Number: 079489305

Premarket Exempt : No

Product Code : GEH

Prescription Use : Yes

Device Count : 1

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