MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPK

GUDID 40616258009917

Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLLO,T-CON,SPK, MC,JA2) (85231316)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258009917
• NIH Device Record Key: 971a2bc9-9206-488f-9729-1ef599b9bc89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Stellant Sterile Disposable Syringe
• Version Model Number: SDS-CTP-SPK
• Catalog Number: SDS-CTP-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	00616258009919 [Primary]
GS1	40616258009917 [Package]; Contains: 00616258009919; Package: [20 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: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [MEDRAD® Stellant Sterile Disposable Syringe]

• 40616258009894: KIT,SYR,STLNT,SJS-PT-J,MC,JA2 (85231499)
• 10616258007950: Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,SYR,STLNT,APOL
• 10616258007943: Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,SGL,STLNT,APO
• 10616258007936: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL
• 10616258007929: Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,DUAL,STLNT,APOL
• 00616258007465: Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,SYR,STLNT,APOL
• 10616258007455: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOL
• 10616258007448: Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (KIT,DUAL,STLNT,APOL
• 10616258007042: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL
• 10616258005253: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT - STELLANT DUAL S
• 10616258005222: Stellant Single Syringe and Quick Fill Tube (CT - STELLANT SINGLE SYR KIT, QFT) (60728842)
• 10616258005215: Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT-STELLANT SINGLE
• 10616258005208: Stellant Single Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (CT - STELLANT SIN
• 10616258005185: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (CT-STELLANT DUAL SYR
• 10616258005178: Stellant Dual Syringe Kit with LPDCT with T-Connector and 1 quick fill tube (CT - STELLANT DUAL
• 40616258009917: Stellant Dual Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (KIT,DUAL,STLNT,APOLL
• 40616258022206: STELLANT,KIT,SYR,CT,SNGL,QFT,MC,WLD (86698617)
• 40616258022183: STLNT,KIT,SYR,CT,SNGL,60”,SPK,MC,WLD (86698242)
• 40616258022169: STLNT,KIT,SYR,CT,SNGL,60”,QFT,MC,WLD (86698226)
• 40616258022138: STLNT,KIT,SYR,CT,DUAL,TCON,SPK,MC,WLD (86698188)
• 40616258022121: STLNT,KIT,SYR,CT,DUAL,SAL SPK,MC,WLD (86698161)
• 40616258022084: STLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,WLD (86698153)
• 70616258010662: STLNT,KIT,SYR,CT,D,QFT,FLS3,150ML,RW (85074229)
• 40616258024644: STELLANT,KIT,SYR,CT,SNGL,QFT,MC,CORE (87622673)
• 40616258024637: STLNT,SYR,SNGL,60",SPK,MC,CORE,SAX (87622665)
• 40616258024620: STLNT,KIT,SYR,CT,SNGL,60",QFT,MC,CORE (87622789)
• 40616258024606: STLNT,SYR,DUAL,TCON,SPK,MC,CORE,SAX (87623017)
• 40616258024590: STLNT,KIT,SYR,CT,DUAL,SAL SPK,MC,CORE (87623009)
• 40616258024583: STLNT,KIT,SYR,CT,DUAL,TCON,QFT,MC,CORE (87622991)