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) (8) Drape, surgical, exempt (PUI) (2)

Premarket Exempt

No Yes

Clear

Halyard - 30680651796975 Catalog Number :

Device Description : HYHL100 PERINEAL COVER DRAPE W/TAPE 15X40CM

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 500

Halyard - 30680651797040 Catalog Number : 79704

Device Description : Femoral Angiography Drape, 76 in. x 124 in./193 cm x 314 cm - HANDI-BIN

Device Class :

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 160

Halyard - 30680651797095 Catalog Number :

Device Description : SURG F-A DRAPE XLNG 16

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 16

Halyard - 30680651797118 Catalog Number :

Device Description : SURGICAL FEMRL-ANGIO DRAPE 18

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 18

Halyard - 30680651797132 Catalog Number : 79713

Device Description : HALYARD* Preparation Pad-24 X 48-65-65

Device Class : 2

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 65

Halyard - 30680651797316 Catalog Number :

Device Description : UTILITY DRAPE W/TAPE 550

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 550

Halyard - 30680651797422 Catalog Number :

Device Description : HYHL100 CYSTOSCOPY DRAPE 30

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 120

Halyard - 30680651797453 Catalog Number :

Device Description : HYHL100 FENESTRATED DRAPE 211X241, 12CM ROUND

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 30

Halyard - 30680651797460 Catalog Number :

Device Description : HYHL100 FENESTRATED DRAPE W/TAPE, 50X75CM

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 160

Halyard - 30680651797477 Catalog Number :

Device Description : HYHL100 FENESTRATED DRAPE 76X76CM, 3X5CM RECTANGULAR

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 300

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