OptiLIF Endo, Direct Visualization System

Basic Information

• Brand Name: OptiLIF Endo, Direct Visualization System
• Primary DI: M7401050040
• Version / Model: 05-01-24-6
• Catalog Number: 105-0040
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-19
• Public Version: 2
• Public Version Date: 2024-01-05
• Public Version Status: Update
• Public Device Record Key: 1630f2ef-f08c-48c2-b884-3bd518723970

Device Description

TF Endo Tubular Retractor, 6.6mm x 163mm x 40° Bevel

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37142	Endoscopic-access dilator, reusable	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7401050040	HIBCC

Customer Contacts

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