MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike SSS-SPK

GUDID 40616258022220

STELLANT,KIT,SYR,CT,SNGL,SPK,MC,WLD (86698625)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258022220
• NIH Device Record Key: 182ae208-f5f2-4208-994c-0273272b3492
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike
• Version Model Number: SSS-SPK
• Catalog Number: SSS-SPK
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258022222 [Primary]
GS1	40616258022220 [Package]; Contains: 00616258022222; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023183

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike]

• 40616258009900: Stellant Single Syringe and Spike(CT - STELLANT SINGLE SYR KIT, SPIKE) MC,JA2 (85230077)
• 40616258022220: STELLANT,KIT,SYR,CT,SNGL,SPK,MC,WLD (86698625)