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

RETRACTOR (GAD) (6) Catheter And Tip, Suction (JOL) (3) Light, Surgical, Carrier (FSZ) (1)

Premarket Exempt

No Yes

Clear

PhotonSaber Y - 00816728020431 Catalog Number : ES4Y

Device Description : Y Aspirator, Metal Tip

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

PhotonSaber Y - 00816728020448 Catalog Number : ES3Y

Device Description : Y Aspirator, Taper Tip

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

PhotonSaber Y - 00816728020462 Catalog Number : ES1Y

Device Description : Y Aspirator, Bulb Tip

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : JOL

Prescription Use : Yes

Device Count : 1

Eikon - 00816728020486 Catalog Number : C3550ANN

Device Description : LT Retractor, A-N, 35mm & 50mm Narrow

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon - 00816728020493 Catalog Number : C3550ANXN

Device Description : LT Retractor, A-N, 35mm & 50mm Extra Narrow

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

N/A - 00816728020547 Catalog Number : A25D

Device Description : Deaver 25mm Wide Retractor

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

N/A - 00816728020554 Catalog Number : A38D

Device Description : Deaver 38mm Wide Retractor

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

PhotonGuide - 00816728020646 Catalog Number : 104015

Device Description : Illuminator, Wide/Flat

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : FSZ

Prescription Use : Yes

Device Count : 1

Eikon - 00816728020660 Catalog Number : C40XN

Device Description : LT Retractor, 40 mm, Extra Narrow

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon - 00816728020677 Catalog Number : C40N

Device Description : LT Retractor, 40mm, Narrow

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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