Avanos Medical, 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

Probe, radiofrequency lesion (GXI) (8) NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (BSP) (2)

Premarket Exempt

No Yes

Clear

AVANOS - 00193493000166 Catalog Number : MCKA3-17-75-2

Device Description : MCKA3-17-75-2 AVNS,MULTI-RF,RFQKIT,17GX75X2,3 PROBES

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000173 Catalog Number : MCKA3-17-150-4

Device Description : MCKA3-17-150-4 AVNS,MULTI-RF,RFQKIT,17GX150X4,3 PROBES

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000180 Catalog Number : 181A471

Device Description : UNIVERSAL BLOCK TRAY, QTY 20

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000197 Catalog Number : CRA-TBK-1

Device Description : CRA-TBK-1 AVNS,TUBING KIT, ONE PROBE,1

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000203 Catalog Number : CRA-TBK-2

Device Description : CRA-TBK-2 AVNS,TUBING KIT, TWO PROBES,1

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000234 Catalog Number : 181A472

Device Description : UNIVERSAL BLOCK TRAY, QTY 10

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

COOLIEF* - 00193493000265 Catalog Number : TDX-Y-TSW-TDP2

Device Description : COOLIEF* TRANSDISCAL* Cooled Radiofrequency Connector Cable

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

COOLIEF* - 00193493000272 Catalog Number : TDX-PMG-PPU

Device Description : COOLIEF* Cooled Radiofrequency Peristaltic Pump Connector Cable

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 20

AVANOS* - 00193493000289 Catalog Number : PMX-BAY-MRF

Device Description : Multi-Radiofrequency Module

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS* - 00193493000296 Catalog Number : PMX-BAY-BAY

Device Description : Radiofrequency Connector Cable

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

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