C1™ DEVICE

GUDID 10850200006305

C1™ DEVICE Base Package Type - Each Each sterile package contains (1) single patient use disposable C1™ Suturing Device. Rotating shaft.

LSI Solutions, Inc.

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Primary Device ID10850200006305
NIH Device Record Key647ca239-8c13-406e-aa85-2763bc1f3742
Commercial Distribution StatusIn Commercial Distribution
Brand NameC1™ DEVICE
Version Model Number022000
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

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Length24 Centimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850200006308 [Primary]
GS110850200006305 [Package]
Contains: 00850200006308
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

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