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, Self-Retaining, For Neurosurgery (GZT) (6) Operating Room Accessories Table Tray (FWZ) (3) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

TSI - 00851797006764 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 5 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006771 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 8 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006788 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 10 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006795 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 13 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006801 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 16 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006818 Catalog Number :

Device Description : CONCAVE SPATULA, 75 MM, 20 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006825 Catalog Number :

Device Description : ROTATABLE TABLE CLAMP

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006832 Catalog Number :

Device Description : ANGLED ARTICULATING ARM, RACK CLAMP

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006849 Catalog Number :

Device Description : STERILIZATION TRAY, ML-2009

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

TSI - 00851797006856 Catalog Number :

Device Description : FLEX ARM LIGHT CABLE HOLDER, LARGE

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

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