ecoFIX

Basic Information

• Brand Name: ecoFIX
• Primary DI: 03760304681264
• Version / Model: Complete ecoFIX basket - 1st row with automatic grasper
• Catalog Number: EPA9000006
• Company Name: S.B.M
• Labeler DUNS: 772462123
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-12
• Public Version: 1
• Public Version Date: 2024-06-20
• Public Version Status: New
• Public Device Record Key: f60e6141-528b-4037-9915-1089a8a49321
• Distribution End Date: 2024-06-14

Device Description

Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the ecoFIX implant for rotator cuff repair (1st row) with automatic grasper.

Device Characteristics

• Single Use: No
• 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: 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: Yes
• 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
44091	Arthroscopic surgical procedure kit, non-medicated, reusable	A collection of various surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760304681264	GS1