Identity
- Trade Name
- SET Rotarex™S 8 F x 85 cm 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
- 80238 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
- 07640142811879 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
- 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 Gauge — 8 French FDA UDICatheter Working Length — 85 Centimeter FDA UDI
Category: Mechanical atherectomy system catheter/handpiece
SET Rotarex™S 8 F x 85 cm by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system catheter/handpiece.
- SET Rotarex™S 6 F x 110 cm — Straub Medical AG · Class II
- SET Rotarex™S 6 F x 135 cm — Straub Medical AG · Class II
- SET Rotarex™S 8 F x 110 cm — Straub Medical AG · Class II
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
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Straub Medical AG
Sources (1)
- FDA UDI 0eecca27-6389-4b99-8928-e4506289c63e 37 fields · synced Jun 8, 2026