Identity
- Trade Name
- VSI Radial™ introducer sheath FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction. FDA UDI
- Model / Reference
- 8986 FDA UDI
- Description
- The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20689860 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Dimensions & Sizes
- Size
- Length — 11 Centimeter FDA UDICatheter Gauge — 4 French FDA UDI
Category: Vascular catheter introduction set, nonimplantable
VSI Radial™ introducer sheath by Vascular Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI 9da6bfc7-1f50-4a13-80e2-2c7222a1e8c7 35 fields · synced May 30, 2026