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) (10)

Premarket Exempt

No Yes

Clear

Surgical Direct - B382SD10329100 Catalog Number : SD10329-10

Device Description : Outer seal for item #SD10079

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10341590 Catalog Number : SD1034159

Device Description : 5.5mm 15cm Obturator for Trocars, Extremely Sharp Durable Triangular Tip

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10342090 Catalog Number : SD1034209

Device Description : 5.5mm 20cm Obturator for Trocars, Extremely Sharp Durable Triangular Tip, 20cm W 5.5mm 20cm Obturator for Trocars, Extremely Sharp Durable Triangular Tip, 20cm Working Length

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103490 Catalog Number : SD10349

Device Description : 5.5mm Obturator for Trocars, Extremely Sharp Durable Triangular Tip

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10349BL0 Catalog Number : SD10349BL

Device Description : 5.5mm Obturator for Trocars, Blunt Tip

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103590 Catalog Number : SD10359

Device Description : 5.5mm Obturator for Trocars, Cone Tip

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103690 Catalog Number : SD10369

Device Description : 5.5mm Obturator with Safety Shield

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103790 Catalog Number : SD10379

Device Description : 5.5mm Locking Shielded Obturator

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10391090 Catalog Number : SD1039109

Device Description : 10mm Triangular Tip Obturator for Trocar

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD1039109BL0 Catalog Number : SD1039109BL

Device Description : 10mm Blunt Tip Obturator for Trocar

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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