TEDAN SURGICAL INNOVATIONS, L.L.C.

Address:12320 Cardinal Meadow Drive,Sugar Land,TX,77478,US

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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) (4) Instrument, Manual, Surgical, General Use (MDM) (3) Tray, Surgical, Instrument (FSM) (2) Retractor, Fiberoptic (FDG) (1)

Premarket Exempt

No Yes

Clear

Stryker - 00843059100808 Catalog Number :

Device Description : MICRODISCECTOMY INSTRUMENTS TRAY

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Stryker - 00843059100815 Catalog Number :

Device Description : PHANTOM ML RETRACTOR BLADES (L&R), 18MM DIA. X 100MM, CHOCOLATE

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Stryker - 00843059100822 Catalog Number :

Device Description : PHANTOM ML RETRACTOR BLADES (L&R), 18MM DIA. X 110MM, TURQUOISE SPLASH

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Stryker - 00843059100839 Catalog Number :

Device Description : PHANTOM ML RETRACTOR BLADES (L&R), 18MM DIA. X 120MM, PURPLE SPLASH

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Stryker - 00843059100846 Catalog Number :

Device Description : PHANTOM ML STERILIZATION TRAY

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Stryker - 00843059100853 Catalog Number :

Device Description : PHANTOM T-HANDLE FOR RETRACTOR WITH PIVOTING ARMS

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Stryker - 00843059100860 Catalog Number :

Device Description : PHANTOM LIGHT CABLE, REUSABLE

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

Stryker - 00843059100877 Catalog Number :

Device Description : PHANTOM ML BASE RETRACTOR WITH PIVOTING ARMS

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Stryker - 00843059100884 Catalog Number :

Device Description : PHANTOM ML DILATOR #1, 8MM

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Stryker - 00843059100891 Catalog Number :

Device Description : PHANTOM ML PIVOTING CENTER BLADE

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

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