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 - 10680651076493 Catalog Number : 76091-ACM7649

Device Description : HYH-MCV DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651076622 Catalog Number : 76091-ACM7662

Device Description : HYH-NEURO BACK DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651076738 Catalog Number : 76091-ACM7673

Device Description : NEPHROSCOPY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651077032 Catalog Number : 76091-ACM7703

Device Description : HYH-BUTLER CV DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651077100 Catalog Number : 76091-ACM7710

Device Description : NEURO DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651077322 Catalog Number : 76091-ACM7732

Device Description : HYH-LAPAROSCOPY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651077360 Catalog Number : 76091-ACM7736

Device Description : HYH-PED CARDIO DRAPE.

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651077568 Catalog Number : 76091-ACM7756

Device Description : HYH-CHEST DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651077582 Catalog Number : 76091-ACM7758

Device Description : OPHTHALMOLOGY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651077704 Catalog Number : 76091-ACM7770

Device Description : SCI CV Sheet II

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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