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

Light, Surgical, Fiberoptic (FST) (5) Catheter And Tip, Suction (JOL) (4) TRAY, SURGICAL, INSTRUMENT (FSM) (2) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

PhotonSaber F - 00816728020127 Catalog Number : PSF12LR

Device Description : F Aspirator, 12 Fr, Long, Round

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

PhotonSaber F - 00816728020134 Catalog Number : PSF08ST

Device Description : F Aspirator, 8 Fr, Standard, Teardrop

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

PhotonSaber F - 00816728020141 Catalog Number : PSF08LT

Device Description : F Aspirator, 8 Fr, Long, Teardrop

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

PhotonBlade - 00816728020158 Catalog Number : PB1

Device Description : The PhotonBlade is an RF device coupled with illumination that is indicated for The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.

Device Class : 2

Duns Number: 196548481

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

N/A - 00816728020196 Catalog Number : FC1S

Device Description : Single Fiber Optic Cable 10ft

Device Class : 2

Duns Number: 196548481

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

N/A - 00816728020202 Catalog Number : FC1SP

Device Description : Single Fiber Optic Cable 10ft, Pink

Device Class : 2

Duns Number: 196548481

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

N/A - 00816728020226 Catalog Number : FC1B

Device Description : Bifurcated Fiber Optic Cable 11.5ft

Device Class : 2

Duns Number: 196548481

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Eikon LT Sterilization Tray - 00816728020240 Catalog Number : ST2B

Device Description : Sterilization Tray

Device Class : 1

Duns Number: 196548481

Premarket Exempt : No

Product Code : FST, FSM

Prescription Use : Yes

Device Count : 1

Eikon LT Sterilization Tray - 00816728020257 Catalog Number : ST1C

Device Description : Sterilization Tray

Device Class : 1

Duns Number: 196548481

Premarket Exempt : No

Product Code : FST, FSM

Prescription Use : Yes

Device Count : 1

PhotonSaber F - 00816728020424 Catalog Number : 1911273

Device Description : F Aspirator, 12 Fr, Standard, Round

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

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