SET Rotarex™S 8 F x 85 cm 80238

GUDID 07640142811879

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.

Straub Medical AG

Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece Mechanical atherectomy system catheter/handpiece
Primary Device ID07640142811879
NIH Device Record Key0eecca27-6389-4b99-8928-e4506289c63e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET Rotarex™S 8 F x 85 cm
Version Model Number80238
Catalog Number80238
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+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
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 Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter
Catheter Gauge8 French
Catheter Working Length85 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142811879 [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

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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
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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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