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) (9) Retractor, Fiberoptic (FDG) (1)

Premarket Exempt

No Yes

Clear

TSI - 00851797006863 Catalog Number :

Device Description : LIGHT CABLE, STANDARD CURVE, 10'

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FDG

Prescription Use : No

Device Count : 1

TSI - 00851797006870 Catalog Number :

Device Description : NEURO FLEX ARM, 36CM (14")

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006887 Catalog Number :

Device Description : NEURO FLEX ARM, 39CM (15")

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006894 Catalog Number :

Device Description : NEURO FLEX ARM, 17CM (7")

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006900 Catalog Number :

Device Description : PATTIE TRAY

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006917 Catalog Number :

Device Description : SPATULA HOLDER

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006924 Catalog Number :

Device Description : UNIVERSAL SPATULA HOLDER

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006931 Catalog Number :

Device Description : SINGLE FLEX ARM HOLDER

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006948 Catalog Number :

Device Description : SKULL CLAMP DUAL FLEX ARM HOLDER

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

TSI - 00851797006955 Catalog Number :

Device Description : DUAL STARBURST TABLE CLAMP

Device Class : 1

Duns Number: 791619393

Premarket Exempt : Yes

Product Code : FWZ

Prescription Use : No

Device Count : 1

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