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) (9) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

Surgical Direct - B382SD0107A0 Catalog Number : SD0107A

Device Description : 7 1/2" Bayonet Monopolar Forceps, 2mm Straight Tip

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD036090 Catalog Number : SD03609

Device Description : 5mm Flexible Laparoscopic Retractor, Round Shape, Formable Retractor

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD045090 Catalog Number : SD04509

Device Description : Laparoscope/Instrument Holder

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD04509D0 Catalog Number : SD04509D

Device Description : Laparoscope/Instrument Holder, with Delrin Instrument Holder

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD050090 Catalog Number : SD05009

Device Description : Laparoscopic Instrument and Scope Holder, with Flex Arm & Universal Instrument H

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD053080 Catalog Number : SD 05308

Device Description : 5mm 36cm Strong Curved Dissector, Double Action, 20mm Jaw Length, Rotating - Insert

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD05308320 Catalog Number : SD 0530832

Device Description : 5mm 32cm Strong Curved Dissector, Double Action, 20mm Jaw Length, Rotating - Insert

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD05309S0 Catalog Number : SD05309S

Device Description : 10mm 32cm Angled Dissector, Insulated Stainless Steel Non-Locking Rotating Handl

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD054090 Catalog Number : SD05409

Device Description : Laparoscopic Instrument and Scope Holder with Flex Arm & Universal Instrument Ho

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD055090 Catalog Number : SD05509

Device Description : Laparoscopic Instrument and Scope Holder, with Twin Flex Arms, and Universal Ins

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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