Mermaid Medical A/S

Address:Frydensbergvej 25,Stenloese 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

Catheter, Embolectomy (DXE) (2) Catheter, Biliary, Diagnostic (FGE) (1) Needle, Aspiration And Injection, Disposable (GAA) (1) Short-Term Intravascular Filter Catheter (PNS) (1)

Premarket Exempt

No Yes

Clear

M-Drain - 15711055003015 Catalog Number : D10706025

Device Description : The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. "The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These kits are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D105/D107/D110/D112/D130 (Direct Access) or D120 (Seldinger Type) depending on the method used to provide access."

Device Class : 2

Duns Number: 308951313

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Fine Needle Aspiration - 15711055003343 Catalog Number : N10125050

Device Description : The FNA biopsy needle is used for removing cytologic specimens.

Device Class : 1

Duns Number: 308951313

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

D*Clot® HD Rotational Thrombectomy System - 15711055004326 Catalog Number : T10106040

Device Description : The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical decl The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts

Device Class :

Duns Number: 308951313

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

D*Clot® HD Rotational Thrombectomy System - 15711055004333 Catalog Number : T10106065

Device Class :

Duns Number: 308951313

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

Angel Catheter - 15711055005002 Catalog Number :

Device Description : SHORT-TERM INTRAVASCULAR FILTER CATHETER

Device Class :

Duns Number: 308951313

Premarket Exempt : No

Product Code : PNS

Prescription Use : Yes

Device Count : 1

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