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

Operating Room Accessories Table Tray (FWZ) (5) Instrument, Manual, Surgical, General Use (MDM) (2) Retractor (GAD) (2) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Stryker - 00843059100907 Catalog Number :

Device Description : PHANTOM COUNTER RETRACTOR WITH PIVOTING ARMS

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

Stryker - 00843059100914 Catalog Number :

Device Description : PHANTOM K-WIRE - 1.4MM x 9 INCHES - DISPOSABLE (6 PER PACK)

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

TSI - 00843059100921 Catalog Number :

Device Description : RETRACTOR RING

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00843059100938 Catalog Number :

Device Description : EXTENSION BAR

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00843059100945 Catalog Number :

Device Description : RING CLAMP

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00843059100952 Catalog Number :

Device Description : BLADE HOLDER

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

TSI - 00843059100969 Catalog Number :

Device Description : HEX WRENCH

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : No

Device Count : 1

TSI - 00843059100976 Catalog Number :

Device Description : ARTICULATING RING CONNECTOR

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00843059100983 Catalog Number :

Device Description : ACCESSORY ARM

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00843059100990 Catalog Number :

Device Description : ALIF BLADE, 50 X 60 MM, GOLD

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

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