O&M HALYARD, INC.

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) (7) Drape, surgical (KKX) (2) Mask, surgical (FXX) (1)

Premarket Exempt

No Yes

Clear

Halyard - 10036000624844 Catalog Number : 62484

Device Description : KTP,2000,HW,WH,KNIT H,50

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 300

Halyard - 10680651050165 Catalog Number : 76092-ACM5016

Device Description : SHOULDER ARTHROSCOPY TOP DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651050189 Catalog Number : 76094-ACM5018

Device Description : HYH SHOULDER BOT. W/CON

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Halyard - 10680651050301 Catalog Number : 76094-ACM5030

Device Description : PCMC ADOLESCENT STERNOTOMY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651050318 Catalog Number : 76094-ACM5031

Device Description : HYH INFANT STERNOTOMY

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651050325 Catalog Number : 76094-ACM5032

Device Description : PCMC Neonatal Drape

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651050332 Catalog Number : 76094-ACM5033

Device Description : PCMC ADULT STERNOTOMY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651050592 Catalog Number : 76094-ACM5059

Device Description : CRANIOTOMY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651051049 Catalog Number : 76092-ACM5104

Device Description : OCCUPLASTY DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

Halyard - 10680651052022 Catalog Number : 76092-ACM5202

Device Description : HYH PREMIE DRAPE

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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