KaVo NOMAD Pro 2

GUDID EKAV101329290

KaVo NOMAD Pro 2, US

Imaging Sciences International

Diagnostic x-ray system generator, hand-held

• Primary Device ID: EKAV101329290
• NIH Device Record Key: 259d1a8e-04be-4a37-a262-d046b2de039d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KaVo NOMAD Pro 2
• Version Model Number: 1.013.2929
• Company DUNS: 800111106
• Company Name: Imaging Sciences International
• 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: 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
HIBCC	EKAV101329290 [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: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [KaVo NOMAD Pro 2]

• EKAV101377880: KaVo NOMAD Pro 2, CA
• EKAV101329300: KaVo NOMAD Pro 2, GBL
• EKAV101329290: KaVo NOMAD Pro 2, US