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MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- SYSTEM,DUAL,STELLANT,FLEX (85577026) FDA UDI
- Model / Reference
- Stellant FLEX FDA UDI
- Description
- SYSTEM,DUAL,STELLANT,FLEX (85577026) FDA UDI
Identifiers
- Catalog Number
- FLEX FDA UDI
- Primary DI / UDI-DI
- 00616258011219 FDA UDI
- 510(k) Number
- K173773 FDA UDI
- FDA Product Code
- IZQ FDA UDIDXT FDA UDI
- GMDN Term
- CT contrast medium injection system, line-powered, mobile 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
MR Unsafe FDA UDI
Category: CT contrast medium injection system, line-powered, mobile
MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as CT contrast medium injection system, line-powered, mobile.
- EDA Clip — Bracco Injeneering · Class II
- CT Expres™ 3D — Bracco Injeneering · Class II
- EDA Module Kit — Bracco Injeneering · Class II
- CT Exprès™ - Bottle Insulator — Bracco Injeneering · Class II
- Injector Mounting Arm, Left — Bracco Injeneering · Class II
- MEDRAD® Centargo CT Injection System — IMAXEON PTY LTD · Class II
- Injector — Bracco Injeneering · Class II
- Injector Mounting Arm, Right — Bracco Injeneering · Class II
Cleared under the same submission
K173773 also covers:
- MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade) — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — Bayer Medical Care Inc.
- MEDRAD® Stellant FLEX Syringe Kit — 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 (1)
- FDA UDI b7e712c5-531d-4a00-ad3c-2717f151b1d8 36 fields · synced Jun 9, 2026