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Savion Flx™

FDA UDI

Class II (US FDA UDI)

by Boston Scientific

Identity

Trade Name
SAVION FLX™ FDA UDI
Generic Name
Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name
Guidewire with ICE™ Hydrophilic coating FDA UDI
Model / Reference
H7493942230010 FDA UDI
Description
Guidewire with ICE™ Hydrophilic coating FDA UDI

Identifiers

Primary DI / UDI-DI
08714729978817 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Cardiac/peripheral vascular guidewire, single-use 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

Dimensions & Sizes

Size
Outer Diameter — 0.37 Millimeter FDA UDI
Length — 300 Centimeter FDA UDI
Outer Diameter — 0.014 Inch FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use

Savion Flx™ by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac/peripheral vascular guidewire, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI b7b80ddf-5f26-4afe-9dd0-500693af7753 34 fields · synced May 30, 2026