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

• Primary Device ID: 10850200006091
• NIH Device Record Key: f25d2234-6b51-479b-9dfa-a9f87b8c08d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TK® Ti-KNOT® DEVICE
• Version Model Number: 030404
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Length: 31 Centimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006094 [Primary]
GS1	10850200006091 [Package]; Contains: 00850200006094; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-12

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• 10850200006510 - SEW-EASY®: 2024-10-29 SEW-EASY® DEVICE KIT, 5mm
• 10850200006527 - SEW-EASY®: 2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm
• 00850012846253 - multiSTATION™: 2024-10-07 DOC-X 15™ EXTENDER
• 00850012846352 - multiSTATION™: 2024-10-07 DOC-X 25™ EXTENDER
• 00850012846369 - multiSTATION™: 2024-10-07 DOC-X 45™ EXTENDER