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) (8) Drape, surgical (KKX) (2)

Premarket Exempt

No Yes

Clear

Halyard - 10680651052039 Catalog Number : 76092-ACM5203

Device Description : HYH APH PEDIATRIC DRAPE

Device Class :

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651052688 Catalog Number : 76094-ACM5268

Device Description : HYH MEMPHIS VA NEPHRO

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651053067 Catalog Number : 76094-ACM5306

Device Description : HYH-BILATERAL EXTRIMITY

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651053739 Catalog Number : 76092-ACM5373

Device Description : Upper Body Drape

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651054538 Catalog Number : 76094-ACM5453

Device Description : PED. BILATERAL LIMB DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651055610 Catalog Number : 76095-ACM5561

Device Description : ADULT CRANIOTOMY INCISE DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651055764 Catalog Number : 76092-ACM5576

Device Description : HYH-MYERS THYROID DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651056129 Catalog Number : 76093-ACM5612

Device Description : ACM HIP DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651056297 Catalog Number : 76092-ACM5629

Device Description : HYH PEDIATRIC DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651056327 Catalog Number : 76093-ACM5632

Device Description : BILATERAL PEDIATRIC LIMB DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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