MEDRAD® Stellant CT Injection System SCT-310, SCT-321, SCT-322

GUDID 00616258008943

"DUAL STELLANT W/CERTEGRA WKS (60726807)"

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258008943
• NIH Device Record Key: aee5f954-014b-4f49-9109-c1e313639802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant CT Injection System
• Version Model Number: Stellant D-CE
• Catalog Number: SCT-310, SCT-321, SCT-322
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258008943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082905

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [MEDRAD® Stellant CT Injection System]

• 00616258021348: CT – STELLANT D DUAL INJECTOR, UPGRADED (86184524)
• 00616258021331: DUAL,STELLANT W/CERTEGRA WKS, UPGRADED (86184516)
• 00616258010588: REFURBISHED SYSTEM,SNGL SYR,STELLANT SX (84856798)
• 00616258010571: REFURBISHED SYSTEM,DUAL SYR,STELLANT D (59875705)
• 00616258010250: SYSTEM,DUAL,STELLANT D,COUNTRY SPECIFIC (85077198)
• 00616258010243: SYSTEM STELLANT SX, COUNTRY SPECIFIC (85073052)
• 00616258008981: REFURBISHED SYSTEM,DUAL SYR,STELLANT D, MC (60728095)
• 00616258008974: REFURBISHED SYSTEM,SNGL SYR,STELLANT SX, MC (60728087)
• 00616258008967: "SYSTEM,DUAL SYRINGE,STELLANT,901,MC (84334154)"
• 00616258008950: "ASSY, KIT, STELLANT MOBILE,MC (60766175)"
• 00616258008943: "DUAL STELLANT W/CERTEGRA WKS (60726807)"
• 00616258008912: "CT - STELLANT D DUAL INJECTOR,MC (60726726)"
• 00616258008905: "CT - STELLANT SX SINGLE INJECTOR,MC (60726734)"
• 00616258008899: "SSH 100, HEAT MAINTAINER (85276654)"
• 00616258008882: "SSH 200, HEAT MAINTAINER (85276581)"
• 00616258008875: "Assy, Kit, Hand Switch, with Ferrite (85276530)"
• 00616258020860: STELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286)
• 00616258020822: STELLANT,SYS,INJ,D,DUAL SYR,LATAM2,4ED (85920278)
• 00616258020662: MAINTAIN,SYR HEAT,STEL,FLS2,UDI,BATCH,JA (85864483)
• 00616258025131: SCT-310, SCT-321, SCT-322