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MEDRAD® Spectris Solaris EP MR Injection System

FDA UDIEUDAMED

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
ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,MC2 (85858599) FDA UDI
Model / Reference
Spectris Solaris EP FDA UDI
Description
ASSY,TOP LEVEL,SPECTRIS SOLARIS EP,MC2 (85858599) FDA UDI

Identifiers

Catalog Number
3012011 FDA UDI
Primary DI / UDI-DI
00616258020280 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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (2)

  • FDA UDI 18556eee-efb7-4251-8520-9f8edfc1164f 35 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026