AKUNAH REFLECT

Basic Information

• Brand Name: AKUNAH REFLECT
• Primary DI: 09309002093005
• Version / Model: REFLECT
• Company Name: AKUNAH PTY LTD
• Labeler DUNS: 748490069
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-25
• Public Version: 1
• Public Version Date: 2025-04-02
• Public Version Status: New
• Public Device Record Key: 68802eca-5c3a-4030-9e5c-c40e1a61c602

Device Description

Akunah Reflect Planning Software

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46470	Orthopaedic/craniofacial implantation planning software	A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09309002093005	GS1

Premarket Submissions

Submission Number	Supplement Number
K222987	000