4CIS® INSTRUMENT SYSTEM

Basic Information

• Brand Name: 4CIS® INSTRUMENT SYSTEM
• Primary DI: 08800033349532
• Version / Model: 5901-0425
• Catalog Number: 5901-0425
• Company Name: SOLCO BIOMEDICAL CO.,LTD.
• Labeler DUNS: 687844241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-24
• Public Version: 1
• Public Version Date: 2020-05-04
• Public Version Status: New
• Public Device Record Key: 7f61d0a8-b1fa-4095-8df5-ba6e1885ff11

Device Description

4CIS® Marlin Trial 17x15 18x16 10degree

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
60725	Transfemoral amputation tissue-reinforcement implant trial	A copy of a final transfemoral amputation tissue-reinforcement implant intended to be used during orthopaedic surgery to accurately size a transfemoral amputation tissue-reinforcement implant (medullary canal rod and bulb) prior to implantation, following a transfemoral (above-the-knee) amputation. It is typically made of metal or polymer materials and includes trial rods and/or trial bulbs; it is typically available in a set of trial implants of graduated sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800033349532	GS1