NEOSURGICAL LIMITED

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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) Guide, Needle, Surgical (GDF) (1)

Premarket Exempt

No Yes

Clear

neoClose AnchorGuide Regular Port Closure Kit US - 05391529640026 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of:05391529640002; neoClose Anchor Laparoscopy wound closure system kit consists of:05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qty 10 and05391529640019; neoClose AutoAnchor x2 PAck US; Model Number NCA2-U; Qty 10

Device Class :

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose AnchorGuide XL Port Closure Kit US - 05391529640064 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of: 05391529640040; neoClose Ancho Laparoscopy wound closure system kit consists of: 05391529640040; neoClose AnchorGuide12/15 & XL US; Model Number NCAXL-U; Qty 10 and 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 10

Device Class : 2

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose AnchorGuide Regular Port Closure Kit x2 US - 05391529640088 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of: 05391529640002; neoClose Ancho Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA5/15-U; Qty 10 and 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 10.

Device Class : 2

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose 2 AutoAnchor Pack US - 05391529640101 Catalog Number :

Device Description : Laparoscopy wound closure system pack consists of: 05391529640019; neoClose Auto Laparoscopy wound closure system pack consists of: 05391529640019; neoClose AutoAnchor x2 Pack US; Model Number NCA2-U Qty 15

Device Class :

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 15

neoClose 4 AutoAnchor Pack US - 05391529640125 Catalog Number :

Device Description : Laparoscopy wound closure system pack consists of: 05391529640057; neoClose Auto Laparoscopy wound closure system pack consists of: 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 15.

Device Class :

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 15

neoClose AnchorGuide 5/12 Port Closure Kit US (1 Port) - 05391529640163 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of: 05391529640149; neoClose Ancho Laparoscopy wound closure system kit consists of: 05391529640149; neoClose AnchorGuide 5/12 US; Model Number NCA512-U; Qty 10 and 05391529640156; neoClose 2 AutoAnchor Pack US; Model Number NCAA2-U; Qty 10.

Device Class : 2

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose AnchorGuide 8/15 Port Closure Kit US (1 Port) - 05391529640194 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of: 05391529640187; neoClose Ancho Laparoscopy wound closure system kit consists of: 05391529640187; neoClose AnchorGuide 8/15 US; Model Number NCA815-U; Qty 10 and 05391529640156; neoClose 2 AutoAnchor Pack US; Model Number NCAA2-U; Qty 10

Device Class : 2

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port) - 05391529640224 Catalog Number :

Device Description : Laparoscopy wound closure system kit consists of: 05391529640002; neoClose Ancho Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qty 10 and 05391529640217; neoClose 4 AutoAnchor Pack US; Model Number NCAA4-U; Qty 10

Device Class : 2

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

neoClose AnchorGuard - 05391529640460 Catalog Number :

Device Description : Laparoscopy wound closure system guide consists of: 05391529640422; neoClose Anc Laparoscopy wound closure system guide consists of: 05391529640422; neoClose AnchorGuard; Model Number NCAG-U

Device Class :

Duns Number: 896844250

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 15

neoClose 2 Anchor (Long Driver) US - 05391529640552 Catalog Number :

Device Description : Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anch Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U

Device Class :

Duns Number: 896844250

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 15

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