NOMAD™ handheld X-ray system FP 0012

GUDID EKAV085000150

Handheld X-ray

ARIBEX, INC.

Diagnostic x-ray system generator, hand-held

• Primary Device ID: EKAV085000150
• NIH Device Record Key: 54eed95c-92ce-4249-b968-035aae74395a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOMAD™ handheld X-ray system
• Version Model Number: 0.850.0015
• Catalog Number: FP 0012
• Company DUNS: 169065526
• Company Name: ARIBEX, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18663405522
• Email: support@aribex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV085000150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051795

FDA Product Code

• EHD: UNIT, X-RAY, EXTRAORAL WITH TIMER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [NOMAD™ handheld X-ray system]

• EKAV085000420: Handheld X-ray
• EKAV085000150: Handheld X-ray
• EKAV085000040: 0.850.0004
• EKAV085000030: Handheld X-ray
• EKAV085000020: Handheld X-ray
• EKAV085000010: Handheld X-ray
• EKAV085000000: Handheld X-ray