Elite HD+ Light Body Normal Set C203030

GUDID EZHIC2030301

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material

• Primary Device ID: EZHIC2030301
• NIH Device Record Key: 2f142663-90a2-414c-97ce-a1d466999d35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HD+ Light Body Normal Set
• Version Model Number: C203030
• Catalog Number: C203030
• 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: 100 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EZHIC2030300 [Unit of Use]
HIBCC	EZHIC2030301 [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+ Light Body Normal Set]

• EZHIC2030350: Addition silicone impression material
• EZHIC2030301: Addition silicone impression material