TK® Ti-KNOT® DEVICE

GUDID 10850200006091

TK® Ti-KNOT® DEVICE Each sterile package contains (1) single patient use disposable TITANIUM KNOT® placement device. Base Package Type - Each

LSI Solutions, Inc.

Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable Suture clasp, non-bioabsorbable
Primary Device ID10850200006091
NIH Device Record Keyf25d2234-6b51-479b-9dfa-a9f87b8c08d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTK® Ti-KNOT® DEVICE
Version Model Number030404
Company DUNS603420183
Company NameLSI Solutions, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 Centimeter
Outer Diameter5 Millimeter
Length31 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
GS100850200006094 [Primary]
GS110850200006091 [Package]
Contains: 00850200006094
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 Number3
Public Version Date2018-07-06
Device Publish Date2016-05-12

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