COR-KNOT MICRO 032890

GUDID 10850012846663

COR-KNOT MICRO® XL DEVICE TWIN PACK

LSI Solutions, Inc.

Suture clasp, non-bioabsorbable

• Primary Device ID: 10850012846663
• NIH Device Record Key: 9458b2d9-6cc5-49cd-8c6b-b581fccad496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COR-KNOT MICRO
• Version Model Number: 032890
• Catalog Number: 032890
• Company DUNS: 603420183
• Company Name: LSI Solutions, Inc.
• Device Count: 2
• 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: false
• Serial Number: false
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850012846666 [Primary]
GS1	10850012846663 [Package]; Contains: 00850012846666; Package: Case [8 Units]; In Commercial Distribution
GS1	40850012846664 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202551

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-16
• Device Publish Date: 2025-12-08

On-Brand Devices [COR-KNOT MICRO]

• 10850012846427: COR-KNOT® MICRO Twin Pack
• 10850012846663: COR-KNOT MICRO® XL DEVICE TWIN PACK
• 10850012846656: COR-KNOT MICRO® XL