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MEDRAD® Stellant CT Injection System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SCT-310
Identity
- Trade Name
- MEDRAD® Stellant CT Injection System with Certegra Workstation EUDAMEDMEDRAD® Stellant CT Injection System FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- MEDRAD® Stellant CT Injection System with Certegra Workstation EUDAMEDSTELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286) FDA UDI
- Model / Reference
- SCT-310 EUDAMEDSCT-310, SCT-321, SCT-322 FDA UDIStellant D-CE FDA UDI
- Description
- STELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286) FDA UDI
Identifiers
- Catalog Number
- SCT-310, SCT-321, SCT-322 FDA UDI
- Primary DI / UDI-DI
- 00616258025131 EUDAMEDFDA UDI00616258020860 EUDAMEDFDA UDI00616258025186 EUDAMED
- Basic UDI-DI
- 0616258TFCN-0082IIbZ3 EUDAMED
- 510(k) Number
- K082905 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- Z11039013 ANGIOGRAPHIC INJECTORS EUDAMED
- GMDN Term
- CT contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
MEDRAD® Stellant CT Injection System by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K082905 also covers:
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface ISI 700 Module — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface ISI 800 Module — Bayer Medical Care Inc.
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
- Bayer Medical Care Inc.
Sources (5)
- FDA UDI c3852463-3e8d-463a-a09c-85941ab13d64 36 fields · synced Oct 7, 2026
- FDA UDI bdf9a860-4498-4b79-a582-b941e98435ee 36 fields · synced May 30, 2026
- EUDAMED 0620d8b5-d737-44ef-9410-f47e96e6664b 61 fields · synced Jul 9, 2026
- EUDAMED bb68c12a-ca33-49d4-bfcc-acd5eaecbd3d 61 fields · synced Jul 26, 2026
- EUDAMED 22b4b985-ec72-4f6b-81f5-2c29c8b92446 61 fields · synced Jul 26, 2026