Rotarex™S 6 F x 135 cm 80333
GUDID 07640142811824
The Rotarex™S catheter (gauge 6F; length 135 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature.
Straub Medical AG
Mechanical atherectomy system catheter/handpiece| Primary Device ID | 07640142811824 |
| NIH Device Record Key | 161a32b7-7b5d-4451-a544-13ac24b754a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rotarex™S 6 F x 135 cm |
| Version Model Number | 80333 |
| Catalog Number | 80333 |
| 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 | false |
| 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 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com | |
| Phone | +41817200460 |
| info@straubmedical.com |
Device Dimensions
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
| Catheter Gauge | 6 French |
| Catheter Working Length | 135 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142811824 [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 | 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 |
Trademark Results [Rotarex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTAREX 79233933 5759861 Live/Registered |
LUXEMBOURG PATENT COMPANY S.A. 2017-12-20 |
 ROTAREX 79055967 3728503 Live/Registered |
Straub Medical AG 2008-05-06 |
 ROTAREX 75859948 2557769 Live/Registered |
Straub Medical AG 1999-11-29 |
 ROTAREX 73084406 1134985 Dead/Cancelled |
EX-CELL-O GMBH 1978-08-24 |
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