Surgical Direct, Inc.

Address:909 SOUTH WOODLAND BLVD.,DELAND,FL,32720,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

Laparoscope, General & Plastic Surgery (GCJ) (8) Image, Illumination, Fiberoptic, For Endoscope (FFS) (2)

Premarket Exempt

No Yes

Clear

Surgical Direct - B382SD101090 Catalog Number : SD10109

Device Description : 11mm Trocar, with Trumpet Valve

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10111590 Catalog Number : SD1011159

Device Description : 11mm 15cm Trocar with Automatic Valve, Dismountable

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101190 Catalog Number : SD10119

Device Description : 11mm Trocar, with Automatic Valve

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101212590 Catalog Number : SD10121259

Device Description : 12.5mm Trocar with Multifunctional Valve, Dismountable

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101290 Catalog Number : SD10129

Device Description : 11mm Trocar (Screw in Type), Cannula Set with Multifunction Valve

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10132590 Catalog Number : SD1013259

Device Description : 13mm 20cm Trocar with Automatic Valve, Dismountable

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10142090 Catalog Number : SD1014209

Device Description : 5.5mm 20cm Threaded Shaft for Exchange, 20cm Working Length

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101490 Catalog Number : SD10149

Device Description : 5.5mm Threaded Shaft for Exchange

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101531150 Catalog Number : SD10153115

Device Description : 5mm 10' Autoclavable Fiber Optic Light Cable, Light Source Type: Universal Fitti 5mm 10' Autoclavable Fiber Optic Light Cable, Light Source Type: Universal Fitting, Scope Type: Wolf, Large Snap On Fitting

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : FFS

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD101531210 Catalog Number : SD10153121

Device Description : 5mm 10' Autoclavable Fiber Optic Light Cable, Armored Ends, Clear, Light Source 5mm 10' Autoclavable Fiber Optic Light Cable, Armored Ends, Clear, Light Source Type: Universal Fitting Scope Type: Wolf, Large Snap On Fitting

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : FFS

Prescription Use : Yes

Device Count : 1

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