NXTHERA, INC.

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Filters

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, electrosurgical, endoscopic (with or without accessories) (KNS) (4) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (KNS) (1)

Premarket Exempt

Clear

rezum Generator - 00855357006003 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

rezum - 00855357006010 Catalog Number :

Device Description : Delivery Device Kit for BPH

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

Rezūm Accessory Kit - 00855357006034 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

rezum Generator - 08714729986843 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

rezum Generator - 08714729986850 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

rezum Generator - 08714729986867 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

rezum Generator - 08714729986874 Catalog Number :

Device Class : 2

Duns Number: 947824194

Premarket Exempt : No

Product Code : KNS

Prescription Use : Yes

Device Count : 1

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