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

Premarket Exempt

No Yes

Clear

Halyard - 10680651056334 Catalog Number : 76093-ACM5633

Device Description : HYH-D & C HYSTOROSCOPY

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651056815 Catalog Number : 76094-ACM5681

Device Description : HYH-HYSTEROSCOPY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057065 Catalog Number : 5706

Device Description : HYH NEURO TABLE DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057102 Catalog Number : 76092-ACM5710

Device Description : HYH UNIVERSAL PACK II

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057119 Catalog Number : 76091-ACM5711

Device Description : HYH LITHOTHOMY PACK

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057362 Catalog Number : 76093-ACM5736

Device Description : HYH-CRANI DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057522 Catalog Number : 76092-ACM5752

Device Description : Pedi-Lap Drape

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651057706 Catalog Number : 76093-ACM5770

Device Description : BREAST/CHEST DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651057744 Catalog Number : 76092-ACM5774

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651057782 Catalog Number : 76092-ACM5778

Device Description : HYH-FENESTRATED EAR DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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