Mi-KNOT™ 031700

GUDID 10850200006534

Mi-KNOT™ DEVICE

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

• Primary Device ID: 10850200006534
• NIH Device Record Key: 1a27168b-c1a1-4d2c-a0a3-eb330c0e35fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mi-KNOT™
• Version Model Number: 031700
• Catalog Number: 031700
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: true
• 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: +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
• Phone: +1(866)575-3493
• Email: regulatorydpt@lsisolutions.com

Device Dimensions

• Length: 11.326 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006537 [Primary]
GS1	10850200006534 [Package]; Contains: 00850200006537; 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: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2020-03-13

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