Elite HD+ Maxi Tray Material Fast Set C202320

GUDID EZHIC2023201

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material

• Primary Device ID: EZHIC2023201
• NIH Device Record Key: b91be48d-ed58-4c06-a508-8e45cb199f02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HD+ Maxi Tray Material Fast Set
• Version Model Number: C202320
• Catalog Number: C202320
• 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

• Total Volume: 760 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EZHIC2023200 [Unit of Use]
HIBCC	EZHIC2023201 [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

On-Brand Devices [Elite HD+ Maxi Tray Material Fast Set]

• EZHIC2023301: Addition silicone impression material
• EZHIC2023201: Addition silicone impression material