← Back to catalogue

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
"ASSY,CONTRAST HOLDER,MC (84277118)" FDA UDI
Model / Reference
CHD 100 MR FDA UDI
Description
"ASSY,CONTRAST HOLDER,MC (84277118)" FDA UDI

Identifiers

Catalog Number
CHD 100 MR FDA UDI
Primary DI / UDI-DI
00616258008790 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bayer Medical Care Inc.

Sources (1)

  • FDA UDI 0b123b49-b534-4bd3-a31b-3665e4b793bb 35 fields · synced Jun 9, 2026