INTRA-KNOT™ QUICK LOAD®

GUDID 10850200006282

INTRA-KNOT™ QUICK LOAD® Base Package Type - Pouch / 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 ID: 10850200006282
• NIH Device Record Key: 35194fe6-11af-44d9-b7af-5182acffa324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTRA-KNOT™ QUICK LOAD®
• Version Model Number: 032040
• 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

• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Lumen/Inner Diameter: 0.035 Inch
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter
• Length: 40 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850200006285 [Primary]
GS1	10850200006282 [Package]; Contains: 00850200006285; Package: Box / Inner Pack [12 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: true
• Device Is Sterile: true

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

[10850200006282]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-04

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