Apex

Basic Information

• Brand Name: Apex
• Primary DI: 05391529583095
• Version / Model: INS-1129
• Catalog Number: INS-1129
• Company Name: ORTHOXEL DESIGNATED ACTIVITY COMPANY
• Labeler DUNS: 985596830
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-29
• Public Version: 1
• Public Version Date: 2021-02-08
• Public Version Status: New
• Public Device Record Key: 609c8825-a091-488a-8015-a6d98486f86a

Device Description

Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw)

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: 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
HTW	Bit, Drill	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32390	Fluted surgical drill bit, reusable	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391529583095	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4.25 mm x 300.0 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Ambient Storage and Handling