Rotarex®S 6F 110cm (Straub Medical®) 80208

GUDID 07640142810278

The Rotarex®S catheter (gauge 6F; length 110 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature.

Straub Medical AG

Mechanical atherectomy system catheter/handpiece
Primary Device ID07640142810278
NIH Device Record Key37c1d2ed-5c12-4807-8156-8fcbe40ef6a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotarex®S 6F 110cm (Straub Medical®)
Version Model NumberVersion 1.0
Catalog Number80208
Company DUNS488489766
Company NameStraub Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com

Device Dimensions

Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French
Catheter Working Length110 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142810278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-17
Device Publish Date2020-02-07

Devices Manufactured by Straub Medical AG

07640142810407 - Aspirex® S 6F 110 cm 2022-07-08 The Aspirex® S catheter (gauge 6F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810438 - Aspirex® S 6F 135cm 2022-07-08 The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810452 - Aspirex® S 8F 85cm 2022-07-08 The Aspirex® S catheter (gauge 8F; length 85cm) is over-the-wire, single use, percutaneous device for the treatment of occlusio
07640142810483 - Aspirex® S 8F 110cm 2022-07-08 The Aspirex® S catheter (gauge 8F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810506 - Aspirex® S 10F 110cm 2022-07-08 The Aspirex® S catheter (gauge 10F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlus
07640142810735 - Guidewire 0.025 6/270cm angled 2022-07-08 The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip coated
07640142811312 - SET Aspirex™ S 6F 110cm2022-07-08 The Aspirex™ S Thrombectomy Catheter Set is composed of one Aspirex™ S Thrombectomy Catheter (gauge 6F; length 110cm), one A
07640142811329 - SET Aspirex™ S 6F 135cm2022-07-08 The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspir

Trademark Results [Rotarex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROTAREX
ROTAREX
79233933 5759861 Live/Registered
LUXEMBOURG PATENT COMPANY S.A.
2017-12-20
ROTAREX
ROTAREX
79055967 3728503 Live/Registered
Straub Medical AG
2008-05-06
ROTAREX
ROTAREX
75859948 2557769 Live/Registered
Straub Medical AG
1999-11-29
ROTAREX
ROTAREX
73084406 1134985 Dead/Cancelled
EX-CELL-O GMBH
1978-08-24

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