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) (3) Wound Dressing Kit (MCY) (2) CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) (BZN) (1) System, network and communication, physiological monitors (MSX) (1) Tape And Bandage, Adhesive (KGX) (1) System, Skin Closure (MKY) (1) Light, Surgical, Carrier (FSZ) (1)

Premarket Exempt

No Yes

Clear

Eikon LT Adapt Smoke Evacuation - 00816728021452 Catalog Number : A155SE

Device Description : LT Adapt Smoke Evacuation Retractor, 155mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021476 Catalog Number : A155WSE

Device Description : LT Adapt Smoke Evacuation Retractor, 155mm, Wide

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Eikon LT Adapt Smoke Evacuation - 00816728021490 Catalog Number : A175SE

Device Description : LT Adapt Smoke Evacuation Retractor, 175mm

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

PhotonGuide - 00816728021650 Catalog Number : 104008

Device Description : Illuminator, Narrow/Flat

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : FSZ

Prescription Use : Yes

Device Count : 1

Zip 4 Surgical Skin Closure Device - 00853114007195 Catalog Number : PS2040

Device Description : Zip 4 Surgical Skin Closure Device

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

ZipSeal 16 Surgical Skin Closure Kit - 00853114007225 Catalog Number : PS1163

Device Description : ZipSeal 16 Surgical Skin Closure Kit

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : MCY

Prescription Use : Yes

Device Count : 1

ZipSeal 24 Surgical Skin Closure Kit - 00853114007232 Catalog Number : PS1243

Device Description : ZipSeal 24 Surgical Skin Closure Kit

Device Class : 2

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : MCY

Prescription Use : Yes

Device Count : 1

Zip PreLoc 2 Wound Closure Device - 00853114007270 Catalog Number : PS3002

Device Description : Zip PreLoc 2 Wound Closure Device

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : MKY

Prescription Use : Yes

Device Count : 1

Connected OR Cart - 00858701006360 Catalog Number : 240-099-155

Device Description : .

Device Class : 1

Duns Number: 187502109

Premarket Exempt : Yes

Product Code : BZN

Prescription Use : No

Device Count : 1

Engage Medical Device Alert Notification System (EMDAN) - 00860002177779 Catalog Number : 910-01947

Device Class : 2

Duns Number: 078470558

Premarket Exempt : No

Product Code : MSX

Prescription Use : No

Device Count : 1

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