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

Drape, surgical, exempt (PUI) (8) GOWN, SURGICAL (FYA) (2)

Premarket Exempt

No Yes

Clear

Halyard - 30680651485633 Catalog Number : 48563NS

Device Description : 48563NS AECHROM,CREW,SRGGWN,NOSTER,3XL,28

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 28

Halyard - 30680651485640 Catalog Number : 48564NS

Device Description : 48564NS AECHROM,CREW,SRGGWN,NOSTER,3XLXLNG,24

Device Class : 2

Duns Number: 079375431

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 24

Halyard - 30680651487798 Catalog Number : 48779NS

Device Description : HYH ACM,F-A,SRGDRP,LRG,6

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 8

Halyard - 30680651487897 Catalog Number : 48789

Device Description : HYH,HIP,SHT,88X131,12

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 12

Halyard - 30680651487903 Catalog Number : 48790

Device Description : HYH,CARDIO,SPLDRP,88X140,8

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 8

Halyard - 30680651488030 Catalog Number : 48803

Device Description : HYH,CYSLEG,SHT,87X100,20

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 20

Halyard - 30680651488085 Catalog Number : 48808

Device Description : HYH,L-PELV,SHTABC,22

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 22

Halyard - 30680651488092 Catalog Number : 48809

Device Description : HYH,L-CHOL,DRAPE,14

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 14

Halyard - 30680651488115 Catalog Number : 48811

Device Description : HYH,L-CHOL,DRPABC,14

Device Class : 2

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 14

Halyard - 30680651706684 Catalog Number : 70668NS

Device Description : U-Drape w/Tape

Device Class :

Duns Number: 079375431

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 18

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