Lina Medical ApS

Address:FORMERVANGEN 5,GLOSTRUP Hovedstaden,DK

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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

Retractor (GAD) (4) Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) (KNF) (3) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Laparoscope, Gynecologic (And Accessories) (HET) (1)

Premarket Exempt

No Yes

Clear

LiNA SeaStar™ - 05708265000456 Catalog Number : 4000-S-VL

Device Description : single use retractor ring; VL model (V-shape/Large)

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LiNA SeaStar™ - 05708265000463 Catalog Number : 4000-S-VS

Device Description : single use retractor ring; VS model (V-shape/Small)

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LiNA SeaStar™ - 05708265000470 Catalog Number : 4000-S-VV

Device Description : single use retractor ring VV model (V-shape/V-shape)

Device Class : 1

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LiNA PowerBlade™ - 05708265001019 Catalog Number : 5005-160

Device Description : Bipolar Cutting & Coagulation forceps, 5mm, 3m cable, 4mm pins, straight, length 160mm

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LiNA PowerBlade™ - 05708265001033 Catalog Number : 5005-C-160

Device Description : Bipolar Cutting & Coagulation forceps, 5mm, 3m cable, 4mm pins, curved jaws and Bipolar Cutting & Coagulation forceps, 5mm, 3m cable, 4mm pins, curved jaws and knife, length 160mm

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

LiNA Gold Loop™ - 05708265001316 Catalog Number : EL-160-8

Device Description : Endoscopic Monopolar Loop for LSH. Small loop- 160-80mm, 8mm connector

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

LiNA Gold Loop™ - 05708265001354 Catalog Number : EL-200-8

Device Description : Endoscopic Monopolar Loop for LSH. Large loop- 200-100mm, 8mm connector

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

LiNA SeaStar™ - 05708265002269 Catalog Number : 4000-S-Q

Device Description : single use retractor ring; Squared model

Device Class :

Duns Number: 305088619

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

LiNA Gold Loop™ - 05708265003419 Catalog Number : EL-240-8

Device Description : Endoscopic Monopolar Loop for LSH. X-large loop-240-120mm, 8mm connector

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : KNF

Prescription Use : Yes

Device Count : 1

LiNA Xcise™, Laparoscopic Morcellator - 05708265004508 Catalog Number : MOR-1515-1

Device Description : 15mm battery powered morcellator system with obturator

Device Class : 2

Duns Number: 305088619

Premarket Exempt : No

Product Code : HET

Prescription Use : Yes

Device Count : 1

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