Identity
- Trade Name
- Guidewire 0.025 6/270cm angled FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip. The guidewire is used to initially cross through the area to be treated. To be used with Straub Medical catheters. FDA UDI
- Model / Reference
- 80265 FDA UDI
- Description
- The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip. The guidewire is used to initially cross through the area to be treated. To be used with Straub Medical catheters. FDA UDI
Identifiers
- Catalog Number
- 80265 FDA UDI
- Primary DI / UDI-DI
- 07640142811305 FDA UDI
- 510(k) Number
- K220270 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
No
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
- Guidewire Diameter — 0.0025 Inch FDA UDIGuidewire Length — 270 Centimeter FDA UDI
Category: Peripheral vascular guidewire, manual
Guidewire 0.025 6/270cm angled by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 1958155a-47ca-4b71-b179-7ff452f94bc5 37 fields · synced May 30, 2026