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) (7) Wire, Guide, Catheter (DQX) (4)

Premarket Exempt

Clear

Rotarex™S 6 F x 135 cm - 07640142811824 Catalog Number : 80333

Device Description : The Rotarex™S catheter (gauge 6F; length 135 cm) is over-the-wire, single use, p The Rotarex™S catheter (gauge 6F; length 135 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature.

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Rotarex™S 8 F x 85 cm - 07640142811831 Catalog Number : 80334

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

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

Rotarex™S 8 F x 110 cm - 07640142811848 Catalog Number : 80335

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

Device Class : 2

Duns Number: 488489766

Premarket Exempt : No

Product Code : MCW

Prescription Use : Yes

Device Count : 1

SET Rotarex™S 6 F x 110 cm - 07640142811855 Catalog Number : 80236

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 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 6 F x 135 cm - 07640142811862 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 sterile 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 8 F x 85 cm - 07640142811879 Catalog Number : 80238

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 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 8 F x 110 cm - 07640142811886 Catalog Number : 80239

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 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

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