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 Laparoscopic Instrument and Scope Holder, with Flex Arm & Universal Instrument Holder, with Clamp and Swivel Ball

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 10mm 32cm Angled Dissector, Insulated Stainless Steel Non-Locking Rotating Handle, with Flushport, Single Piece

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 Laparoscopic Instrument and Scope Holder with Flex Arm & Universal Instrument Holder, includes clamp and extension arm

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 Laparoscopic Instrument and Scope Holder, with Twin Flex Arms, and Universal Instrument Holders, Includes Clamps and Extension Arm

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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