Elite HD+ Maxi Monophase Normal Set C202310

GUDID EZHIC2023101

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material
Primary Device IDEZHIC2023101
NIH Device Record Keyf4d418ca-38ca-4a70-b82b-f04830c71d53
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite HD+ Maxi Monophase Normal Set
Version Model NumberC202310
Catalog NumberC202310
Company DUNS432971034
Company NameZHERMACK SPA
Device Count6
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com
Phone+390425597611
Emailinfo@zhermack.com

Device Dimensions

Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter
Device Size Text, specify0
Total Volume2280 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEZHIC2023100 [Unit of Use]
HIBCCEZHIC2023101 [Primary]

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-09

On-Brand Devices [Elite HD+ Maxi Monophase Normal Set]

EZHIC2023101Addition silicone impression material
EZHIC2023001Addition silicone impression material

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