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

Basic Information

• Brand Name: SET Rotarex®S 8F 85cm (Straub Medical®)
• Primary DI: 07640142810599
• Version / Model: Version 1.0
• Catalog Number: 80238
• Company Name: Straub Medical AG
• Labeler DUNS: 488489766
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-31
• Public Version: 7
• Public Version Date: 2025-09-22
• Public Version Status: Update
• Public Device Record Key: c675ae12-35cb-410b-bb34-7f7f2020d827
• Distribution End Date: 2022-01-01

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	870.4875	2
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59225	Mechanical atherectomy system catheter/handpiece	A sterile catheter with attached handpiece, with a power-driven cutting or abrasive head intended to mechanically disrupt/remove atheroma plaque from the walls of both coronary and peripheral arteries. The operator regulates the energy via a remote control or foot-switch attached to the generator. The handpiece may also serve as a conduit for irrigation, aspiration and placement of a guidewire during surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640142810599	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172315	000
K211738	000

Device Sizes

Type	Value	Unit	Text
Catheter Working Length	85	Centimeter
Catheter Gauge	8	French