Drive System (Straub Medical®) 80300

GUDID 07640142810889

The Drive System consists of three components; the control unit, motor (with cable) and footswitch (with cable).

Straub Medical AG

Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system Mechanical atherectomy/thrombectomy drive system
Primary Device ID07640142810889
NIH Device Record Key1ea921b0-be3b-4eea-9529-d97691f168fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrive System (Straub Medical®)
Version Model NumberVersion 1.0
Catalog Number80300
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142810889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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

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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