SET Rotarex™S 6 F x 110 cm 80236

GUDID 07640142811855

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.

Straub Medical AG

Mechanical atherectomy system catheter/handpiece
Primary Device ID07640142811855
NIH Device Record Key51fd5675-78d9-4500-bc7b-b92b0ced754d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET Rotarex™S 6 F x 110 cm
Version Model Number80236
Catalog Number80236
Company DUNS488489766
Company NameStraub Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
Emailinfo@straubmedical.com
Phone+4181720046
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142811855 [Primary]

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 Date2022-05-12
Device Publish Date2022-05-04

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

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