AiM Accuracy In Marking System

GUDID 00860003024102

AiM Vascular Mapping Kit

AIM MEDICAL TECHNOLOGIES, LLC

Skin marking guide, single-use

• Primary Device ID: 00860003024102
• NIH Device Record Key: 027cab7d-ab21-42e9-83b2-55964572af12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AiM Accuracy In Marking System
• Version Model Number: 69-10050
• Company DUNS: 619056752
• Company Name: AIM MEDICAL TECHNOLOGIES, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003024102 [Primary]
GS1	10860003024109 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053463

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-14
• Device Publish Date: 2020-01-06