Button Holder - Suture Management

Basic Information

• Brand Name: Button Holder - Suture Management
• Primary DI: 09421028111959
• Version / Model: 72205274
• Catalog Number: 72205274
• Company Name: ENZTEC LIMITED
• Labeler DUNS: 592616445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-01
• Public Version: 1
• Public Version Date: 2020-12-09
• Public Version Status: New
• Public Device Record Key: 23dcce85-4f84-4030-a2db-5f9e589aaa1c

Device Description

Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56651	Tendon/ligament graft preparation station post	A component of a graft preparation station designed to be affixed to the station base to help position, clamp and tension a ligament and/or tendon graft being prepared for implantation. This device is typically made of high-grade stainless steel and is available in a variety of sizes and types such as adjustable or fixed graft posts, patellar tendon posts, soft tissue clamp posts, and tensioning posts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421028111959	GS1