ANAX™ 5.5 SPINAL SYSTEM

Basic Information

• Brand Name: ANAX™ 5.5 SPINAL SYSTEM
• Primary DI: 08800037508027
• Version / Model: SFM0200
• Company Name: Innosys Co., Ltd.
• Labeler DUNS: 688811082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-13
• Public Version: 2
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: c1ee01bf-30f5-4529-a3f5-231c999f4138

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: Yes
• 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
FZX	Guide, surgical, instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34827	Tendon/ligament tunneller	A long, hand-held, manual surgical instrument designed to tunnel an artificial passageway along ligament and/or tendon tissue to create a connecting channel. It can have a variety of designs: 1) a long, round, stiff rod that tapers to a rounded point at the distal tip with a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue; or 2) a ring-handled instrument with long, slightly curved arms that join at a pivot point near the distal end, terminating in short grasping arms. It will typically be made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800037508027	GS1