Elite HD+ Light Body Normal Set C203035

GUDID EZHIC2030350

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 IDEZHIC2030350
NIH Device Record Key0ab70847-3c02-4817-b9ef-d631e5cf483b
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite HD+ Light Body Normal Set
Version Model NumberC203035
Catalog NumberC203035
Company DUNS432971034
Company NameZHERMACK SPA
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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

Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0
Total Volume180 Milliliter
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEZHIC2030350 [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+ Light Body Normal Set]

EZHIC2030350Addition silicone impression material
EZHIC2030301Addition silicone impression material

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.