Elite Glass C401610

GUDID EZHIC4016101

Addition silicone Clear Matrix Material

ZHERMACK SPA

Silicone dental impression material

• Primary Device ID: EZHIC4016101
• NIH Device Record Key: 8dd94ef2-01e5-41d5-af1e-7afcbedb11fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite Glass
• Version Model Number: C401610
• Catalog Number: C401610
• Company DUNS: 432971034
• Company Name: ZHERMACK SPA
• Device Count: 2
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +390425597611
• Email: info@zhermack.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EZHIC4016100 [Unit of Use]
HIBCC	EZHIC4016101 [Primary]

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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