Launcher

GUDID 10721902607841

CATHETER LA8EBU35 LA 8F 100CM EB35

MEDTRONIC, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 10721902607841
• NIH Device Record Key: ec02a92f-e2db-47dd-97d4-0f1f72f2ff92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Launcher
• Version Model Number: LA8EBU35
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 8 French
• Length: 100 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters straight in a cool dark area. Do not expose catheters to solvents or ionizing radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10721902607841 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103386

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-07-23
• Device Publish Date: 2016-04-15

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• 00613994905826: CATHETER LA6JR40E LA 6F 85CM JR40
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• 00613994905253: CATHETER LA7HSID LA 7F 90CM HSI
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• 00613994871466: CATHETER LA6RRADA LA 6F 110CM RRAD
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• 00613994870179: CATHETER LA8EBU375D LA 8F 90CM EB375
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• 00613994851451: CATHETER LA6PAPA1 LA 6F 100CM PAPA1
• 00613994851444: CATHETER LA6PAPA LA 6F 100CM PAPA
• 00613994835000: CATHETER LA7EBU40D LA 7F 90CM EB40
• 00613994834997: CATHETER LA7EBU40E LA 7F 85CM EB40
• 00613994834980: CATHETER LA7EBU40F LA 7F 80CM EB40
• 00613994834973: CATHETER LA7EBU40SH LA 7F 100CM EB40
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• 00613994834935: CATHETER LA7EBU45A LA 7F 110CM EB45
• 00613994834928: CATHETER LA7EBU45D LA 7F 90CM EB45
• 00613994834911: CATHETER LA7EBU45SH LA 7F 100CM EB45
• 00613994834904: CATHETER LA7EBU45SHD LA 7F 90CM EB45
• 00613994834898: CATHETER LA7EBU50 LA 7F 100CM EB50
• 00613994834881: CATHETER LA7EBU50D LA 7F 90CM EB50
• 00613994834874: CATHETER LA7EBU50F LA 7F 80CM EB50
• 00613994834867: CATHETER LA7EBU50SH LA 7F 100CM EB50
• 00613994834850: CATHETER LA7EBU50SHD LA 7F 90CM EB50
• 00613994834843: CATHETER LA7ECR35 LA 7F 100CM ECR35
• 00613994834836: CATHETER LA7ECR35SH LA 7F 100CM ECR35
• 00613994834829: CATHETER LA7ECR40 LA 7F 100CM ECR40
• 00613994834812: CATHETER LA7ECR40F LA 7F 80CM ECR40
• 00613994834805: CATHETER LA7ECR40SH LA 7F 100CM ECR40
• 00613994834799: CATHETER LA7EBU40A LA 7F 110CM EB40
• 00613994834782: CATHETER LA7EBU30 LA 7F 100CM EB30
• 00613994834775: CATHETER LA7EBU30D LA 7F 90CM EB30
• 00613994834768: CATHETER LA7EBU30E LA 7F 85CM EB30
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• 00613994834744: CATHETER LA7EBU325 LA 7F 100CM EB325
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