RD® - THE RUNNING DEVICE®

GUDID 10850200006121

RD® - THE RUNNING DEVICE® Bariatric Length Base Package Type - Each Each sterile package contains (1) single patient use disposable Bariatric Length 5 mm RD® Suturing Device.

LSI Solutions, Inc.

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Primary Device ID10850200006121
NIH Device Record Key6efb10c1-2fd0-4fed-9f99-6e675471fc2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRD® - THE RUNNING DEVICE®
Version Model Number021021
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailcustomerservice@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com
Phone+1(866)575-3493
Emailregulatorydpt@lsisolutions.com

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter
Length43 Centimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006124 [Primary]
GS110850200006121 [Package]
Contains: 00850200006124
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCFInstrument, Ligature Passing And Knot Tying

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-06
Device Publish Date2016-09-23

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

10850200006121RD® - THE RUNNING DEVICE® Bariatric Length Base Package Type - Each Each sterile package conta
10850200006114RD® - THE RUNNING DEVICE® Standard Length Base Package Type - Each Each sterile package contai

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