MENIX

Basic Information

• Brand Name: MENIX
• Primary DI: 03760304680540
• Version / Model: MENIX Portal skid
• Catalog Number: MEN9000397
• Company Name: S.B.M
• Labeler DUNS: 772462123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-25
• Public Version: 2
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: ddab0f3f-6f3c-46cb-b873-6d55c12664ec

Device Description

MENIX Portal skid to be used with MENIX and MENIX DUO devices in meniscal repair.

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
66531	Arthroscopic instrument guide	A hand-held, manual, arthroscopic surgical instrument intended to facilitate introduction of another arthroscopic instrument (e.g., surgical introducer, suturing unit, rasp) [not included] into a joint. It is typically a metal shaft with a ridged channel designed to allow instruments to slide down to access the desired surgical anatomy (e.g., meniscus); it is not intended as a retractor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760304680540	GS1