Straub Medical AG

Address:Straubstrasse 12,Wangs Sankt Gallen,CH

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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

Catheter, Peripheral, Atherectomy (MCW) (6) Wire, Guide, Catheter (DQX) (4) Peripheral Mechanical Thrombectomy With Aspiration (QEW) (3) Collector, Urine, (And Accessories) For Indwelling Catheter (KNX) (1)

Premarket Exempt

Clear

Aspirex® S 8F 85cm - 07640142810452 Catalog Number : 80210

Device Description : The Aspirex® S catheter (gauge 8F; length 85cm) is over-the-wire, single use, pe The Aspirex® S catheter (gauge 8F; length 85cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Aspirex® S 8F 110cm - 07640142810483 Catalog Number : 80204

Device Description : The Aspirex® S catheter (gauge 8F; length 110cm) is over-the-wire, single use, p The Aspirex® S catheter (gauge 8F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

Aspirex® S 10F 110cm - 07640142810506 Catalog Number : 80211

Device Description : The Aspirex® S catheter (gauge 10F; length 110cm) is over-the-wire, single use, The Aspirex® S catheter (gauge 10F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : QEW

Prescription Use : Yes

Device Count : 1

SET Rotarex®S 6F 110cm (Straub Medical®) - 07640142810575 Catalog Number : 80236

Device Description : Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW, DQX

Prescription Use : Yes

Device Count : 1

SET Rotarex®S 6F 135cm (Straub Medical®) - 07640142810582 Catalog Number : 80237

Device Description : Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex® Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one drape and one collecting bag.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW, DQX

Prescription Use : Yes

Device Count : 1

SET Rotarex®S 8F 85cm (Straub Medical®) - 07640142810599 Catalog Number : 80238

Device Description : Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length), one drape and one collecting bag.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW, DQX

Prescription Use : Yes

Device Count : 1

SET Rotarex®S 8F 110 cm (Straub Medical®) - 07640142810605 Catalog Number : 80239

Device Description : Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW, DQX

Prescription Use : Yes

Device Count : 1

Collecting Bag 2000ml (Straub Medical®) - 07640142810612 Catalog Number : 10170

Device Description : The collecting bag is non-patient contacting and is attached to the silicon outf The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : KNX

Prescription Use : Yes

Device Count : 1

Control Unit (with cord) (Straub Medical®) - 07640142810872 Catalog Number : 80301

Device Description : The control unit console contains the power supply, system controller, mode sele The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in the rotational speed. The control unit is designed for tabletop use outside the sterile field. The control unit is a part of the Straub Medical Drive System.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Drive System (Straub Medical®) - 07640142810889 Catalog Number : 80300

Device Description : The Drive System consists of three components; the control unit, motor (with cab The Drive System consists of three components; the control unit, motor (with cable) and footswitch (with cable).

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

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