Colorbite Rock C200760

GUDID EZHIC2007601

Addition silicone for Bite Registration

ZHERMACK SPA

Silicone dental impression material
Primary Device IDEZHIC2007601
NIH Device Record Keyb0e66d9d-b75b-4088-aec8-c1bbe3baab4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameColorbite Rock
Version Model NumberC200760
Catalog NumberC200760
Company DUNS432971034
Company NameZHERMACK SPA
Device Count2
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

Device Dimensions

Total Volume100 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEZHIC2007600 [Unit of Use]
HIBCCEZHIC2007601 [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

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