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) (5) RETRACTOR (GAD) (4) Electrosurgical, cutting & coagulation & accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

Eikon - 00816728021001 Catalog Number : C3550AN

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

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon - 00816728021018 Catalog Number : C40R

Device Description : LT Retractor, Rich, 40mm x 38mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon - 00816728021025 Catalog Number : C60R

Device Description : LT Retractor, Rich, 60mm x 45mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon - 00816728021032 Catalog Number : C80R

Device Description : LT Retractor, Rich, 80mm x 60mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

PhotonBlade with Adaptive Smoke Evacuation - 00816728021261 Catalog Number : PB2SE

Device Description : The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Device Class : 2

Duns Number: 196548481

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021377 Catalog Number : A90SE

Device Description : LT Adapt Smoke Evacuation Retractor, 90mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021391 Catalog Number : A90WSE

Device Description : LT Adapt Smoke Evacuation Retractor, 90mm, Wide

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021414 Catalog Number : A135SE

Device Description : LT Adapt Smoke Evacuation Retractor, 135mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021438 Catalog Number : A135WSE

Device Description : LT Adapt Smoke Evacuation Retractor, 135mm, Wide

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021445 Catalog Number : A135WTSE

Device Description : LT Adapt Smoke Evacuation Retractor, 135mm, Wide, Teeth

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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