Freealgin Maxi C300102

GUDID EZHIC3001021

Addition silicone impression material

ZHERMACK SPA

Silicone dental impression material
Primary Device IDEZHIC3001021
NIH Device Record Key1fb77073-c656-4436-bfd3-d87c3361fbf9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreealgin Maxi
Version Model NumberC300102
Catalog NumberC300102
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
HIBCCEZHIC3001020 [Unit of Use]
HIBCCEZHIC3001021 [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 [Freealgin Maxi]

EZHIC3001021Addition silicone impression material
EZHIC3001001Addition silicone impression material

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