Packaged System, KaVo Nomad Pro2, CA 1.013.7789

GUDID EKAV101377890

This is a medical device.

ARIBEX, INC.

Diagnostic x-ray system generator, hand-held

• Primary Device ID: EKAV101377890
• NIH Device Record Key: 39d2631b-a877-44bf-8575-b78d4210782b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Packaged System, KaVo Nomad Pro2, CA
• Version Model Number: 1.013.7789
• Catalog Number: 1.013.7789
• 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: +18882755286
• Email: nomadsupport@kavo.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EKAV101377890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173319

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-02
• Device Publish Date: 2020-02-21

Devices Manufactured by ARIBEX, INC.

• EKAV101320400 - Packaged System, Kavo Nomad Pro2, US: 2020-03-02 This is a medical device.
• EKAV101320410 - Packaged System, Kavo Nomad Pro2, GBL: 2020-03-02 this is a medical device
• EKAV101377890 - Packaged System, KaVo Nomad Pro2, CA: 2020-03-02This is a medical device.
• EKAV101377890 - Packaged System, KaVo Nomad Pro2, CA: 2020-03-02 This is a medical device.
• EKAV085000000 - NOMAD™ handheld X-ray system: 2018-07-06 Handheld X-ray
• EKAV085000010 - NOMAD™ handheld X-ray system: 2018-07-06 Handheld X-ray
• EKAV085000020 - NOMAD™ handheld X-ray system: 2018-07-06 Handheld X-ray
• EKAV085000030 - NOMAD™ handheld X-ray system: 2018-07-06 Handheld X-ray
• EKAV085000040 - NOMAD™ handheld X-ray system: 2018-07-06