SET Rotarex®S 6F 135cm (Straub Medical®) 80237

GUDID 07640142810582

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.

Straub Medical AG

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Primary Device ID07640142810582
NIH Device Record Key08655da8-3266-4b38-a0c6-d28865fbb0b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET Rotarex®S 6F 135cm (Straub Medical®)
Version Model NumberVersion 1.0
Catalog Number80237
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 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
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 Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French
Catheter Working Length135 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142810582 [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 Date2020-02-10
Device Publish Date2020-01-31

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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