Identity
- Trade Name
- Control Unit (with cord) (Straub Medical®) FDA UDI
- Generic Name
- Mechanical atherectomy/thrombectomy drive system FDA UDI
- Device Name
- The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in the rotational speed. The control unit is designed for tabletop use outside the sterile field. The control unit is a part of the Straub Medical Drive System. FDA UDI
- Model / Reference
- Version 1.0 FDA UDI
- Description
- The control unit console contains the power supply, system controller, mode selectors, and has auditory and visual alarms to signify irregularities in the rotational speed. The control unit is designed for tabletop use outside the sterile field. The control unit is a part of the Straub Medical Drive System. FDA UDI
Identifiers
- Catalog Number
- 80301 FDA UDI
- Primary DI / UDI-DI
- 07640142810872 FDA UDI
- 510(k) Number
- K172315 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Mechanical atherectomy/thrombectomy drive system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Control Unit (with cord) (Straub Medical®) by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172315 also covers:
- Drive System (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/220cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/270cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/320cm angled (Straub Medical®) — Straub Medical AG
- SET Rotarex™S 6 F x 110 cm — Straub Medical AG
- SET Rotarex™S 6 F x 135 cm — Straub Medical AG
- SET Rotarex™S 8 F x 110 cm — Straub Medical AG
- SET Rotarex™S 8 F x 85 cm — Straub Medical AG
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Straub Medical AG
Sources (1)
- FDA UDI 8947410a-9560-4b4d-add8-5b529439a4b3 37 fields · synced May 30, 2026