AiM Accuracy In Marking System

Basic Information

• Brand Name: AiM Accuracy In Marking System
• Primary DI: 00860003024102
• Version / Model: 69-10050
• Company Name: AIM MEDICAL TECHNOLOGIES, LLC
• Labeler DUNS: 619056752
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-01-06
• Public Version: 1
• Public Version Date: 2020-01-14
• Public Version Status: New
• Public Device Record Key: 027cab7d-ab21-42e9-83b2-55964572af12

Device Description

AiM Vascular Mapping Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64415	Skin marking guide, single-use	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003024102	GS1
Unit of Use	10860003024109	GS1

Premarket Submissions

Submission Number	Supplement Number
K053463	000