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) (5) Orthopedic Manual Surgical Instrument (LXH) (4) Retractor, Fiberoptic (FDG) (1)

Premarket Exempt

No Yes

Clear

TSI - 00851797006467 Catalog Number :

Device Description : DISTRACTION SCREW, 16 MM, STERILE, 5/BOX

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

TSI - 00851797006474 Catalog Number :

Device Description : QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

TSI - 00851797006481 Catalog Number :

Device Description : QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

TSI - 00851797006498 Catalog Number :

Device Description : QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

TSI - 00851797006504 Catalog Number :

Device Description : LIGHT CABLE, 10', STERILE, 5/BOX

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

TSI - 00851797006511 Catalog Number :

Device Description : MALLEABLE TAPERED BRAIN SPATULA 200 MM, 2.2 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006528 Catalog Number :

Device Description : MALLEABLE TAPERED SPATULA, 200 MM, 3.8 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006535 Catalog Number :

Device Description : MALLEABLE TAPERED SPATULA, 200 MM, 5.8 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006542 Catalog Number :

Device Description : MALLEABLE TAPERED SPATULA, 200 MM, 7.0 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

TSI - 00851797006559 Catalog Number :

Device Description : DAVIS STYLE SPATULA, 6 MM, SST

Device Class : 2

Duns Number: 791619393

Premarket Exempt : No

Product Code : GZT

Prescription Use : No

Device Count : 1

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