FDA UDI
In Commercial Distribution
🇺🇸 United States
SET Rotarex™S 6 F x 135 cm
DI: 07640142811862
·
Model: 80237
·
Straub Medical AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SET Rotarex™S 6 F x 135 cm
- Primary DI
- 07640142811862
- Version / Model
- 80237
- Catalog Number
- 80237
- Company Name
- Straub Medical AG
- Labeler DUNS
- 488489766
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-04
- Public Version
- 4
- Public Version Date
- 2025-09-22
- Public Version Status
- Update
- Public Device Record Key
- fecf4710-d833-4c40-88f4-5e6511f310cb
Device Description
Rotational Excisional Atherectomy System. The Catheter Set includes one Rotarex™S catheter (gauge 6F; length 135 cm), one guidewire (0.018” diameter; 320 cm in length), one sterile 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 | 07640142811862 | GS1 |
Customer Contacts
- Phone
- +1-800-321-4254
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French | |
| Catheter Working Length | 135 | Centimeter |