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

Generator, lesion, radiofrequency (GXD) (3) Probe, radiofrequency lesion (GXI) (3) Anesthesia conduction kit (CAZ) (2) NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) (BSP) (2)

Premarket Exempt

No Yes

Clear

AVANOS* - 00193493000302 Catalog Number : PMX-BAY-19-14

Device Description : Radiofrequency Adapter Cable

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

COOLIEF* - 00193493000319 Catalog Number : CRX-BAY-MCRF

Device Description : COOLIEF* Multi-Cooled Radiofrequency Module

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

COOLIEF* - 00193493000326 Catalog Number : CRX-BAY-CRP

Device Description : COOLIEF* Cooled Radiofrequency Connector Cable

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXI

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000333 Catalog Number : 181A473

Device Description : NERVE BLOCK TRAY

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000340 Catalog Number : CRA-QPU-1-R

Device Description : CRA-QPU-1-R AVNS,REFURB PUMP UNT,PUMP,1

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXD

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000357 Catalog Number : CRA-QPU-1-L

Device Description : CRA-QPU-1-L AVNS,LOANER PUMP UNT,PUMP,1

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXD

Prescription Use : Yes

Device Count : 1

AVANOS - 00193493000371 Catalog Number : 181A474

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 - 00193493000388 Catalog Number : 181A475

Device Description : UNIVERSAL BLOCK TRAY, QTY 20

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : CAZ

Prescription Use : Yes

Device Count : 1

Avanos - 00193493000395 Catalog Number : 181A476

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 - 00193493000401 Catalog Number : CRG-BASIC-L

Device Description : CRG-BASIC-L RF Generator V1.X BASIC 115V/230V LOANER, QTY 1

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : GXD

Prescription Use : Yes

Device Count : 1

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