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MEDRAD® Spectris Solaris EP MR Injection System

FDA UDI

Class II (US FDA UDI)

by Bayer Medical Care Inc.

Identity

Trade Name
MEDRAD® Spectris Solaris EP MR Injection System FDA UDI
Generic Name
MRI contrast medium injection system, battery-powered FDA UDI
Device Name
"iCBC FOR SPECTRIS SOLARIS EP INJECTOR (60727757)" FDA UDI
Model / Reference
3012080 FDA UDI
Description
"iCBC FOR SPECTRIS SOLARIS EP INJECTOR (60727757)" FDA UDI

Identifiers

Catalog Number
3012080 FDA UDI
Primary DI / UDI-DI
00616258008837 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
MRI contrast medium injection system, battery-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: MRI contrast medium injection system, battery-powered

MEDRAD® Spectris Solaris EP MR Injection System by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI contrast medium injection system, battery-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (1)

  • FDA UDI dc41c24a-1202-49c7-8a51-e689c763697d 35 fields · synced Jun 9, 2026