Ena Stain Flow ® ETSVN

GUDID EMICETSVN0

ENA Stain Flow Violet 2g

MICERIUM SPA

Dental composite resin
Primary Device IDEMICETSVN0
NIH Device Record Key65eb9f47-fdec-4480-9c8c-df381a768d33
Commercial Distribution StatusIn Commercial Distribution
Brand NameEna Stain Flow ®
Version Model NumberETSVN
Catalog NumberETSVN
Company DUNS436661136
Company NameMICERIUM SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram
Weight20 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMICETSVN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-14
Device Publish Date2024-08-06

On-Brand Devices [Ena Stain Flow ®]

EMICETSVN1ENA Stain Flow Violet 2g
EMICETSVN0ENA Stain Flow Violet 2g

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