INTRA-KNOT®

Basic Information

• Brand Name: INTRA-KNOT®
• Primary DI: 00850200006285
• Version / Model: 032040
• Catalog Number: 032040
• Company Name: LSI Solutions, Inc.
• Labeler DUNS: 603420183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-04
• Public Version: 5
• Public Version Date: 2022-11-10
• Public Version Status: Update
• Public Device Record Key: 35194fe6-11af-44d9-b7af-5182acffa324

Device Description

INTRA-KNOT® QUICK LOAD® UNIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61353	Suture clasp, non-bioabsorbable	A small, sterile, implantable fastening device designed to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. It is made of non-bioabsorbable materials [e.g., titanium (Ti)] and is typically implanted with a dedicated applicator.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850200006282	GS1	Inner pack	12	In Commercial Distribution
Primary	00850200006285	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100593	000

Device Sizes

Type	Value	Unit	Text
Length	40	Centimeter