FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Motor (with cord) (Straub Medical®)
DI: 07640142810902
·
Model: Version 1.0
·
Straub Medical AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Motor (with cord) (Straub Medical®)
- Primary DI
- 07640142810902
- Version / Model
- Version 1.0
- Catalog Number
- 80302
- 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
- afba06aa-c38c-4a07-ae83-4d1900558aec
- Distribution End Date
- 2025-01-28
Device Description
The Handle / Motor transmits the power between the Control Unit and the catheter. The Handle contains an electric Motor and a magnetic clutch through which the power is transmitted to the catheter. This is part of the Straub Medical Drive System.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 58214 | Mechanical atherectomy/thrombectomy drive system | A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640142810902 | GS1 |
Customer Contacts
- Phone
- +41817200460
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172315 | 000 |