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 ID: 07640142811855
• NIH Device Record Key: 51fd5675-78d9-4500-bc7b-b92b0ced754d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SET Rotarex™S 6 F x 110 cm
• Version Model Number: 80236
• Catalog Number: 80236
• Company DUNS: 488489766
• Company Name: Straub Medical AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com
• Phone: +4181720046
• Email: info@straubmedical.com

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter
• Catheter Gauge: 6 French
• Catheter Working Length: 110 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640142811855 [Primary]

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: 2022-05-12
• Device Publish Date: 2022-05-04

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 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