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) Image, Illumination, Fiberoptic, For Endoscope (FFS) (1)

Premarket Exempt

No Yes

Clear

Surgical Direct - B382SD10290390 Catalog Number : SD1029039

Device Description : 3mm Trocar Seal

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10290490 Catalog Number : SD1029049

Device Description : 4mm Seal for Trocar

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD102990 Catalog Number : SD10299

Device Description : 5.5mm Trocar Seal

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD1029980 Catalog Number : SD10299-8

Device Description : 8mm Trocar Seal

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103090 Catalog Number : SD10309

Device Description : 11mm Sealing Caps

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10309100 Catalog Number : SD10309-10

Device Description : 10mm Sealing Caps

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10309120 Catalog Number : SD10309-12

Device Description : 12.5mm Sealing Caps

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103190 Catalog Number : SD10319

Device Description : Inner Seal for 5.5mm Trocar

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD10327L0 Catalog Number : SD10327L

Device Description : 3mm Fiber Light Cable - Storz Type Scope to Linvatec, Wolf connector, 10ft

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : FFS

Prescription Use : Yes

Device Count : 1

Surgical Direct - B382SD103290 Catalog Number : SD10329

Device Description : Inner Seal for 11mm Hasson Cannula

Device Class : 2

Duns Number: 124367223

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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