Apex

Basic Information

• Brand Name: Apex
• Primary DI: 05391529588700
• Version / Model: INS-1156
• Catalog Number: INS-1156
• Company Name: ORTHOXEL DESIGNATED ACTIVITY COMPANY
• Labeler DUNS: 985596830
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 1
• Public Version Date: 2022-10-12
• Public Version Status: New
• Public Device Record Key: a805f689-73cb-41a1-b754-ff9a63ad9171

Device Description

Flexible IM Reamer Shaft 650mm

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: Yes
• 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
64678	Medullary canal orthopaedic reamer shaft	A flexible cylindrical device intended to accept an orthopaedic reamer head on its distal end and used during a procedure to open and enlarge a medullary canal (e.g., in the femur), for the insertion of devices during prosthesis implantation or for fracture fixation. It is designed to be mounted onto an appropriate surgical tool for manual or powered rotation and is made of flexible materials (e.g., carbon fibre); it has a hollow centre so it can be fed over a guide, and devices to assist the procedure (e.g., drill guiding pin, manual driver) may be provided with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391529588700	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.2 x 227.0mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: ambient storage and handling