C1® Device 022600

GUDID 10850200006619

C1® SUTURING DEVICE (STRAIGHT SHAFT)

LSI Solutions, Inc.

Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use Suturing unit, single-use
Primary Device ID10850200006619
NIH Device Record Key7a188ea2-8268-4a12-bcd2-2154a126d981
Commercial Distribution StatusIn Commercial Distribution
Brand NameC1® Device
Version Model Number022600
Catalog Number022600
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
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
GS100850200006612 [Primary]
GS110850200006619 [Package]
Contains: 00850200006612
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 Number2
Public Version Date2020-03-30
Device Publish Date2020-03-13

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