CARDINAL HEALTH 200, LLC

Address:3651 Birchwood Drive,Waukegan,IL,60085,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

Hysterectomy kit (OJF) (2) Cesarean section tray (OHM) (2) laparoscopy kit (FDE) (2) TRAY, SURGICAL (LRP) (1) Kit, introducer, endoscope (NWU) (1) General surgery tray (kit) (LRO) (1) Labor and Delivery Kit (MLS) (1)

Premarket Exempt

Yes No

Clear

CARDINAL HEALTH - 10885425203680 Catalog Number : SPP99LS1AA

Device Description : STD LAPAROSCOPY PLUS II PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : FDE

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425203697 Catalog Number : SPP99LS2AA

Device Description : LAPAROSCOPY PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : FDE

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425203710 Catalog Number : SPP99LV1AB

Device Description : STANDARD LAVH PLUS II PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : OJF

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425203727 Catalog Number : SPP99LV2AA

Device Description : LAVH PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : OJF

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425324583 Catalog Number : HT99250DTR

Device Description : PEN SRGMRK SKN DISP DL TIP

Device Class : 1

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : LRP

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425482719 Catalog Number : SPP99CS1AA

Device Description : C SECTION PLUS II PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : OHM

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425482764 Catalog Number : SPP99CS6AA

Device Description : C SECTION PLUS II PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : OHM

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425482795 Catalog Number : SPP99CY1AA

Device Description : CYSTO PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425482801 Catalog Number : SPP99DE1AA

Device Description : VAGINAL DELIVERY BASIC PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : LRO

Prescription Use : Yes

Device Count : 1

CARDINAL HEALTH - 10885425482818 Catalog Number : SPP99DE2AA

Device Description : VAGINAL DELIVERY DELUXE PACK

Device Class : 2

Duns Number: 112164780

Premarket Exempt : Yes

Product Code : MLS

Prescription Use : Yes

Device Count : 1

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