Stryker Corporation

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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

DISPENSER, CEMENT (KIH) (5) Injector, vertebroplasty (does not contain cement) (OAR) (5) CEMENT, BONE, VERTEBROPLASTY (NDN) (2) spinal channeling instrument, vertebroplasty (OCJ) (2) Agent, absorbable hemostatic, collagen based (LMF) (1)

Premarket Exempt

No Yes

Clear

Cortoss - 00808232000962 Catalog Number : 2101-0005

Device Description : Bone Augmentation Material

Device Class : 2

Duns Number: 149183167

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

Cortoss - 00808232000979 Catalog Number : 2101-0010

Device Description : Bone Augmentation Material

Device Class : 2

Duns Number: 149183167

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001020 Catalog Number : 2090-0501

Device Description : Syringe Delivery Kit

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : KIH, OAR

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001037 Catalog Number : 2090-0502

Device Description : Plunger Delivery Kit

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OAR, KIH

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001051 Catalog Number : 2090-0504

Device Description : Syringe Delivery Kit

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OAR, KIH

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001068 Catalog Number : 2090-0505

Device Description : Plunger Delivery Kit

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OAR, KIH

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001150 Catalog Number : 2110-0513

Device Description : Side-Port Syringe

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OAR, KIH

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001211 Catalog Number : 2110-0530

Device Description : Directional Bone Tamp

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

Aliquot - 00808232001228 Catalog Number : 2110-0531

Device Description : Directional Bone Tamp

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : OCJ

Prescription Use : Yes

Device Count : 1

VitaPrep - 00808232001242 Catalog Number : 2113-0013

Device Description : Plasma Separator

Device Class : 3

Duns Number: 149183167

Premarket Exempt : No

Product Code : LMF

Prescription Use : Yes

Device Count : 1

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