FDA UDI
In Commercial Distribution
🇺🇸 United States
Rotarex®S 8F 110cm (Straub Medical®)
DI: 07640142810384
·
Model: Version 1.0
·
Straub Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rotarex®S 8F 110cm (Straub Medical®)
- Primary DI
- 07640142810384
- Version / Model
- Version 1.0
- Catalog Number
- 80207
- Company Name
- Straub Medical AG
- Labeler DUNS
- 488489766
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-07
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 0ba723c1-52c7-4247-abdf-3bb379eda10a
Device Description
The Rotarex®S catheter (gauge 8F; length 110 cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in arterial vasculature.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
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 | 07640142810384 | GS1 |
Customer Contacts
- Phone
- +41817200460
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Working Length | 110 | Centimeter | |
| Catheter Gauge | 8 | French |