NEUWAVE MEDICAL, INC.

Address:3529, 3513(Suite 100) and 3543 Anderson Street,Madison,WI,53704,US

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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

SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES (NEY) (4) TABLE AND ATTACHMENTS, OPERATING-ROOM (BWN) (3) System, x-ray, tomography, computed (JAK) (1)

Premarket Exempt

No Yes

Clear

NEUWAVE - 00853719006524 Catalog Number : PD2MSURG

Device Description : Surgical PDM Mount Kit

Device Class : 1

Duns Number: 809758878

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006531 Catalog Number : PRSURGKT

Device Description : Surgical Probe Kit

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006753 Catalog Number : NWC1US1N

Device Description : NW Ablation System, US

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006951 Catalog Number : NWA1US1N

Device Description : NEUWAVE Ablation System with Ablation Confirmation, US

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : JAK, NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006968 Catalog Number : NWC1US1R

Device Description : Refurb NW Ablation System, US

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006975 Catalog Number : ARM1

Device Description : NEUWAVE Arm 1 OR Table Rail

Device Class : 1

Duns Number: 809758878

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00853719006982 Catalog Number : ARM2

Device Description : NEUWAVE Arm 2 Dovetail Rail

Device Class : 1

Duns Number: 809758878

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

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