PURPLE SURGICAL INTERNATIONAL LIMITED

Address:2 Chestnut House,Herts England,GB

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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) (7) Bag, Intestine (KGY) (2) Cannula, Manipulator/Injector, Uterine (LKF) (1)

Premarket Exempt

No Yes

Clear

Uterine Manipulator / Injector 4,5mm - 05051223000600 Catalog Number : PS3111

Device Description : The Uterine manipulator/Injector both a Uterine Manipulator and a Uterine Inject

Device Class :

Duns Number: 239403863

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 1

Hasson Trocar - 05051223000617 Catalog Number : PS3210

Device Description : The Hasson Trocar is designed to provide a port of entry into the abdominal cavi

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Hasson Trocar - 05051223000624 Catalog Number : PS3212

Device Description : The Hasson Trocar is designed to provide a port of entry into the abdominal cavi

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Secondary Trocar with gas port - 05051223000631 Catalog Number : PS3307

Device Description : The Secondary Trocar is used during laparoscopic procedures to create a secondar

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Tissue Retrieval pouch small - 05051223000648 Catalog Number : PS3400

Device Description : The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving

Device Class : 1

Duns Number: 239403863

Premarket Exempt : Yes

Product Code : KGY

Prescription Use : Yes

Device Count : 1

Tissue Retrieval pouch large - 05051223000655 Catalog Number : PS3401

Device Description : The Tissue Retrieval Pouch is used during laparoscopic procedures for retrieving

Device Class : 1

Duns Number: 239403863

Premarket Exempt : Yes

Product Code : KGY

Prescription Use : Yes

Device Count : 1

Auto-shield trocar, ribbed cannula - 05051223000709 Catalog Number : PS3510

Device Description : The AutoShield Trocar is designed to provide a port of entry into the abdominal

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Auto-shield trocar, ribbed cannula - 05051223000716 Catalog Number : PS3512

Device Description : The AutoShield Trocar is designed to provide a port of entry into the abdominal

Device Class :

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Auto-shield trocar, ribbed cannula - 05051223000747 Catalog Number : PS3515

Device Description : The AutoShield Trocar is designed to provide a port of entry into the abdominal

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

Veress Needle - 05051223000792 Catalog Number : PS3700

Device Description : The Veress needle is used to establish a pneumoperitoneum prior to abdominal lap

Device Class : 2

Duns Number: 239403863

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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