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

Guide, wire, catheter, neurovasculature (MOF) (7) Wire, guide, catheter (DQX) (7) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3)

Premarket Exempt

No Yes

Clear

Synchro SELECT - 07613327508581 Catalog Number : SSFT300STR

Device Description : SOFT STRAIGHT Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : MOF, DQX

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508598 Catalog Number : SSFT215PRE

Device Description : SOFT PRE-SHAPED Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : DQX, MOF

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508604 Catalog Number : SSFT300PRE

Device Description : SOFT PRE-SHAPED Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : DQX, MOF

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508611 Catalog Number : SSUP215STR

Device Description : SUPPORT STRAIGHT Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : DQX, MOF

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508628 Catalog Number : SSUP300STR

Device Description : SUPPORT STRAIGHT Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : MOF, DQX

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508635 Catalog Number : SSUP215PRE

Device Description : SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : MOF, DQX

Prescription Use : Yes

Device Count : 1

Synchro SELECT - 07613327508642 Catalog Number : SSUP300PRE

Device Description : SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating

Device Class : 2

Duns Number: 042405446

Premarket Exempt : No

Product Code : DQX, MOF

Prescription Use : Yes

Device Count : 1

Tritanium TL - 07613327509441 Catalog Number : IS4562TPL01

Device Description : Specialty Tritanium TL Fixed Angle Inserter

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Tritanium TL - 07613327509458 Catalog Number : IS4562TPL02

Device Description : Specialty Tritanium TL Ball Tip Draw Rod

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Reliance - 07613327509496 Catalog Number : IS4563REL

Device Description : Specialty Reliance Oval Shaver Set

Device Class : 1

Duns Number: 149183167

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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