RD180® - THE RUNNING DEVICE®

GUDID 10850200006152

10 mm RD180® - THE RUNNING DEVICE® Base Package Type - Each Each sterile package contains (1) single patient use disposable 10 mm RD180® Suturing Device.

LSI Solutions, Inc.

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• Primary Device ID: 10850200006152
• NIH Device Record Key: 9a7435a6-16e4-4edd-be7b-0d1db68defe8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RD180® - THE RUNNING DEVICE®
• Version Model Number: 021330
• Company DUNS: 603420183
• Company Name: LSI Solutions, 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: true
• 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: 866-575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: customerservice@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter
• Length: 33 Centimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006155 [Primary]
GS1	10850200006152 [Package]; Contains: 00850200006155; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100593

FDA Product Code

• HCF: Instrument, Ligature Passing And Knot Tying

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-23

On-Brand Devices [RD180® - THE RUNNING DEVICE®]

• 10850200006206: RD180® SP™ - THE RUNNING DEVICE® Base Package Type - Each Each sterile package contains (1)
• 10850200006152: 10 mm RD180® - THE RUNNING DEVICE® Base Package Type - Each Each sterile package contains (1)
• 10850200006138: 5 mm RD180® - THE RUNNING DEVICE® Base Package Type - Each Each sterile package contains (1) s