Elite HD+ Monophase Normal Set C202020

GUDID EZHIC2020201

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material

• Primary Device ID: EZHIC2020201
• NIH Device Record Key: ac90767e-6d20-4075-8d5f-d57e59d274b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HD+ Monophase Normal Set
• Version Model Number: C202020
• Catalog Number: C202020
• 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
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com
• Phone: +390425597611
• Email: info@zhermack.com

Device Dimensions

• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• Total Volume: 100 Milliliter
• Device Size Text, specify: 0
• 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	EZHIC2020200 [Unit of Use]
HIBCC	EZHIC2020201 [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

Devices Manufactured by ZHERMACK SPA

• 08056000372465 - Dynamic-static Mixing Tips: 2025-04-07 Dynamic-static Mixing Tips
• 08056000372434 - Mixing Tips: 2025-04-07 Mixing Tips
• 08056000372441 - Mixing Tips: 2025-04-07 Mixing Tips
• 08056000372472 - Mixing Tips: 2025-04-07 Oral Tips
• EZHIC2020851 - Mixing Tips: 2022-06-23 Mixing Tips
• EZHIC2020701 - Mixing Tips: 2022-06-22 Mixing Tip
• EZHIC2020801 - Mixing Tips: 2022-06-22 Mixing Tip
• EZHIC2020861 - Mixing Tips: 2022-06-22 Mixing Tips