AOS CALIBRATED STEP DRILL (AO STYLE) 4.8/6.0mm

Basic Information

• Brand Name: AOS CALIBRATED STEP DRILL (AO STYLE) 4.8/6.0mm
• Primary DI: 00848665014105
• Version / Model: 0289
• Company Name: ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
• Labeler DUNS: 117858154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-21
• Public Version: 4
• Public Version Date: 2020-06-24
• Public Version Status: Update
• Public Device Record Key: 445aa9d2-c11c-46a6-a5fc-826008801e30

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: 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: No
• Has Expiration Date: Yes
• 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
47563	Fluted surgical drill bit, single-use, non-sterile	A non-sterile 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, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848665014105	GS1