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

STIMULATOR, NERVE, PERIPHERAL, ELECTRIC (KOI) (3) CATHETER AND TIP, SUCTION (JOL) (2) Neurological tray (OJG) (2) GOWN, SURGICAL (FYA) (1) Pump, Infusion, Elastomeric (MEB) (1) TOOTHBRUSH, MANUAL (EFW) (1)

Premarket Exempt

No Yes

Clear

Halyard - 30609038092998 Catalog Number : 12602

Device Description : Oral Care Suction Toothbrush

Device Class :

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 25

Halyard - 30609038093094 Catalog Number : 12603

Device Description : HALYARD* Oral Care Suction Swab-25-Individual-Angled

Device Class :

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 25

Halyard - 30609038153798 Catalog Number : 12606

Device Description : HALYARD* Suction Valve and Y Adapter

Device Class :

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : No

Device Count : 25

Halyard - 30680651392535 Catalog Number : ES500

Device Description : EZstim* III Peripheral Nerve Stimulator / Nerve Locator

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

Halyard - 30680651447358 Catalog Number : MB500

Device Description : Mounting Bracket for EZstim* III

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

Halyard - 30680651447365 Catalog Number : RK500

Device Description : Repair Kit for EZstim* III

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : KOI

Prescription Use : No

Device Count : 1

Halyard - 30680651476068 Catalog Number : CB004-D

Device Description : ON-Q* Pain Relief System CONVENIENCE KIT with SELECT-A-FLOW*-400 ml -2-14 ml/hr

Device Class : 1

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : No

Device Count : 1

Halyard - 30680651476440 Catalog Number : CB004-RB

Device Description : ON-Q* Pain Relief System Convenience Kit with SELECT-A-FLOW*, 400 ml, 2-14 ml/hr

Device Class : 1

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : OJG

Prescription Use : No

Device Count : 1

Halyard - 30680651476457 Catalog Number : ONQFT

Device Description : ON-Q* Pain Relief System Convenience Kit with Tubing Sets

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : MEB

Prescription Use : No

Device Count : 1

Halyard - 30680651485626 Catalog Number : 48562NS

Device Description : 48562NS AECHROM,CREW,SRGGWN,NOSTER,SML,36

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 36

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