Elite HD+ Maxi Monophase Normal Set C202310

GUDID EZHIC2023101

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: EZHIC2023101
• NIH Device Record Key: f4d418ca-38ca-4a70-b82b-f04830c71d53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite HD+ Maxi Monophase Normal Set
• Version Model Number: C202310
• Catalog Number: C202310
• Company DUNS: 432971034
• Company Name: ZHERMACK SPA
• Device Count: 6
• 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
• Phone: +390425597611
• Email: info@zhermack.com

Device Dimensions

• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter
• Device Size Text, specify: 0
• Total Volume: 2280 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EZHIC2023100 [Unit of Use]
HIBCC	EZHIC2023101 [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 Monophase Normal Set]

• EZHIC2023101: Addition silicone impression material
• EZHIC2023001: Addition silicone impression material