O&M HALYARD, INC.

Address:1 Edison Drive,Alpharetta,GA,30005,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

Drape, Surgical, Exempt (PUI) (6) Drape, surgical (KKX) (4)

Premarket Exempt

No Yes

Clear

Halyard - 10680651057935 Catalog Number : 76094-ACM5793

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651058086 Catalog Number : 76096-ACM5808

Device Description : HYH-HEART PACK

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651060447 Catalog Number : 76092-ACM6044

Device Description : BI-LATERAL IMPERVIOUS SPLIT DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651070255 Catalog Number : 76094-ACM7025

Device Description : HYH BILATERAL MAJOR

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651075151 Catalog Number : 76091-ACM7515

Device Description : HYH-EQUINE DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651075182 Catalog Number : 76091-ACM7518

Device Description : HYH-3/4 DRAPE W/WINDOW

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075397 Catalog Number : 76091-ACM7539

Device Description : Lower Extremity Drape Pack

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075441 Catalog Number : 76091-ACM7544

Device Description : HYH-BREAST-CHEST U-SHEET

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075649 Catalog Number : 76091-ACM7564

Device Description : HYH-CUSTOM HEART DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075687 Catalog Number : 76091-ACM7568

Device Description : HYH-VAGINAL SURGERY DRP

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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