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 - 10680651075793 Catalog Number : 76091-ACM7579

Device Description : Kremer Lasik Drape

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075946 Catalog Number : 76091-ACM7594

Device Description : HYH-PED. BIL LIMB SHEET

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651075953 Catalog Number : 76091-ACM7595

Device Description : HYH-COLIC DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075960 Catalog Number :

Device Description : NEURO MAYO STAND COVER

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651075984 Catalog Number : 76091-ACM7598

Device Description : BAPTIST TESO CATHETER DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651076066 Catalog Number : 76091-ACM7606

Device Description : HYH-BILTAL EXTRMTY DRPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651076080 Catalog Number : 76091-ACM7608

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651076226 Catalog Number : 76091-ACM7622

Device Description : Lower Extremity with Clear View Anesthesia Screen

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651076257 Catalog Number : 76091-ACM7625

Device Description : HYH-HEART BIOPSY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651076363 Catalog Number : 76091-ACM7636

Device Description : BILATERAL LIMB DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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