Identity
- Trade Name
- SET Rotarex®S 8F 85cm (Straub Medical®) FDA UDI
- Generic Name
- Mechanical atherectomy system catheter/handpiece FDA UDI
- Device Name
- Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length), one drape and one collecting bag. FDA UDI
- Model / Reference
- Version 1.0 FDA UDI
- Description
- Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 85 cm), one guidewire (0.018” diameter; 220cm in length), one drape and one collecting bag. FDA UDI
Identifiers
- Catalog Number
- 80238 FDA UDI
- Primary DI / UDI-DI
- 07640142810599 FDA UDI
- FDA Product Code
- MCW FDA UDIDQX FDA UDI
- GMDN Term
- Mechanical atherectomy system catheter/handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 FDA UDI870.1330 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 85 Centimeter FDA UDICatheter Gauge — 8 French FDA UDI
SET Rotarex®S 8F 85cm (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
K211738 also covers:
- 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 c675ae12-35cb-410b-bb34-7f7f2020d827 38 fields · synced May 30, 2026