THERMEDX, LLC

Address:31200 Solon Road,Solon,OH,44139,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

Arthroscope (HRX) (6) Insufflator, Hysteroscopic (HIG) (6) Warmer, Thermal, Infusion Fluid (LGZ) (6)

Premarket Exempt

Clear

Fluid Management System - 00860936000310 Catalog Number :

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

Fluid Management System - 00860936000327 Catalog Number :

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

Luer Lock Set, Single Lumen - 00860936000334 Catalog Number :

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

High Pressure Luer Lock Set, Single Lumen 300mmHg - 00860936000341 Catalog Number :

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

Tubing Set - Single Lumen, Inflow with Dual Outflow - 00860936000358 Catalog Number :

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

Urology Set - 00860936000365 Catalog Number : LL0006

Device Description : Urology Set

Device Class : 2

Duns Number: 022465035

Premarket Exempt : No

Product Code : HRX, LGZ, HIG

Prescription Use : Yes

Device Count : 1

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