U.S. SURGITECH INC.

U.S. SURGITECH INC.

Address:551 Kimberly Drive,Carol Stream,IL,60188,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

Needle, Aspiration And Injection, Disposable (GAA) (5) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (3) Support, Patient Position (CCX) (2)

Premarket Exempt

No Yes

Clear

SurgyPad - 00810014630007 Catalog Number :

Device Class : 1

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

SurgyPad - 00810014630021 Catalog Number :

Device Class : 1

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

SurgyNeedle - 00810014630069 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

SurgyNeedle - 00810014630076 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

SurgyCut - 00810014630083 Catalog Number :

Device Class : 2

Duns Number: 142007082

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SurgyNeedle - 00810014630113 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

SurgyNeedle - 00810014630243 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

SurgyNeedle - 00810014630274 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

SurgyCut - 00810014631011 Catalog Number :

Device Description : SurgyCut L - Hook Foot Control Electrode, 5mm/35cm

Device Class :

Duns Number: 142007082

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SurgyCut - 00810014631073 Catalog Number :

Device Class :

Duns Number: 142007082

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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