SET Rotarex®S 8F 85cm (Straub Medical®) 80238

GUDID 07640142810599

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

• Primary Device ID: 07640142810599
• NIH Device Record Key: c675ae12-35cb-410b-bb34-7f7f2020d827
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SET Rotarex®S 8F 85cm (Straub Medical®)
• Version Model Number: Version 1.0
• Catalog Number: 80238
• Company DUNS: 488489766
• Company Name: Straub Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com
• Phone: +41817200460
• Email: info@straubmedical.com

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French
• Catheter Working Length: 85 Centimeter
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142810599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172315

FDA Product Code

• MCW: Catheter, Peripheral, Atherectomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-01-31

Devices Manufactured by Straub Medical AG

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• 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 110cm: 2022-07-08 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 135cm: 2022-07-08 The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspir