SECQURE SURGICAL, CORP.

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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, Gynecologic (And Accessories) (HET) (8) Bag, Intestine (KGY) (2)

Premarket Exempt

Clear

SECQURE Ultimate - 00863634000408 Catalog Number :

Device Description : Autoshield Trocar, Threaded Cannula, 10mm x 100mm

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000415 Catalog Number :

Device Description : Autoshield Trocar, Threaded Cannula, 12mm x 100mm

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000422 Catalog Number :

Device Description : Dilating Tip Trocar, Threaded Cannula, 5mm x 100mm

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000439 Catalog Number :

Device Description : Dilating Tip Trocar, Threaded Cannula, 10mm x 100mm

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000446 Catalog Number :

Device Description : Dilating Tip Trocar, Threaded Cannula, 12mm x 100mm

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000453 Catalog Number :

Device Description : Autoshield Trocar, Threaded Cannula, 5mm x 70mm, with Additional Cannula

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000460 Catalog Number :

Device Description : EndoRetrieval Pouch with 10mm Introducer & 90mm x 145mm Pouch

Device Class : 1

Duns Number: 079554198

Premarket Exempt : No

Product Code : KGY

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000477 Catalog Number :

Device Description : EndoRetrieval Pouch with 10mm Introducer & 130mm x 180mm Pouch

Device Class : 1

Duns Number: 079554198

Premarket Exempt : No

Product Code : KGY

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000484 Catalog Number :

Device Description : Suction / Irrigation Set with Dual Spike

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

SECQURE Ultimate - 00863634000491 Catalog Number :

Device Description : Suction / Irrigation Set with Single Spike

Device Class : 2

Duns Number: 079554198

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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