NEUWAVE MEDICAL, INC.

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) (8) System, image processing, radiological (LLZ) (1) System, x-ray, tomography, computed (JAK) (1) TABLE AND ATTACHMENTS, OPERATING-ROOM (BWN) (1)

Premarket Exempt

No Yes

Clear

NEUWAVE - 00818913020073 Catalog Number : NWF2HK1N

Device Description : NW Flex System, Hong Kong

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020158 Catalog Number : NWF2SG1N

Device Description : NW Flex System, Singapore

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020172 Catalog Number : NWF2CN1N

Device Description : NW CERTUS Flex System, China

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020189 Catalog Number : DR-000894

Device Description : NEUWAVE Flex MAS, 220-230VAC

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020196 Catalog Number : NWF1US1N

Device Description : NW Flex System, US

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020257 Catalog Number : AC-UPGRADE

Device Description : Upgrade to Certus 140-2.45GHz Ablation Confirmation

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : LLZ, JAK

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020509 Catalog Number : PRS15

Device Description : NEUWAVE PRS Probe 15CM 15ga

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020516 Catalog Number : RCPK

Device Description : Surgical Clip, Dual, 15ga or 17ga Probe, 5 Pack

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

NEUWAVE - 00818913020677 Catalog Number : CTBKT5

Device Description : CT Bed Rail Mount, Flat

Device Class : 1

Duns Number: 809758878

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : Yes

Device Count : 1

Certus® 140 - 00853719006005 Catalog Number : PR15cm - 17ga

Device Description : PR15cm-17ga CertusPR Ablation Probe, 15 cm, 17 ga

Device Class : 2

Duns Number: 809758878

Premarket Exempt : No

Product Code : NEY

Prescription Use : Yes

Device Count : 1

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