DEXIS Titanium Sensor Kit

GUDID EKAV101329130

Imaging Sciences International

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• Primary Device ID: EKAV101329130
• NIH Device Record Key: ddc5a1c0-0937-49af-a126-373f713ced8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Titanium Sensor Kit
• Version Model Number: 1.013.2913
• 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	EKAV101329130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172918

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-21

On-Brand Devices [DEXIS Titanium Sensor Kit]

• EKAV101452100: 1.014.5210
• EKAV101452090: 1.014.5209
• EKAV101452070: 1.014.5207
• EKAV101375650: 1.013.7565
• EKAV101329130: 1.013.2913