EVA SELECT DIRECT 9992413100

GUDID D83399924131000

EVA SELECT DIRECT SIZE 1 SYSTEM

ImageWorks

General-purpose dental x-ray system application software

• Primary Device ID: D83399924131000
• NIH Device Record Key: d7105634-3ebe-41ac-9089-581d43d61dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVA SELECT DIRECT
• Version Model Number: 9992413100
• Catalog Number: 9992413100
• Company DUNS: 833648087
• Company Name: ImageWorks
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D83399924131000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123419

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

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: 2017-08-14

On-Brand Devices [EVA SELECT DIRECT]

• D83399924132050: EVA SELECT DIRECT SIZE 2 SENSOR ONLY
• D83399924132000: EVA SELECT DIRECT SIZE 2 SYSTEM
• D83399924131050: EVA SELECT DIRECT SIZE 1 SENSOR ONLY
• D83399924131000: EVA SELECT DIRECT SIZE 1 SYSTEM