Perfectim 90 Second Blue Velvet

GUDID 10852253006028

PVS Dental Impression Material

J. MORITA U.S.A., INC

Silicone dental impression material
Primary Device ID10852253006028
NIH Device Record Key19a4ec2e-dad7-4786-8e04-bfc55a72751b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfectim 90 Second Blue Velvet
Version Model Number21300550
Company DUNS021866033
Company NameJ. MORITA U.S.A., INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110852253006028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-28
Device Publish Date2016-09-22

On-Brand Devices [Perfectim 90 Second Blue Velvet]

18522530060020PVS Dental Impression Material
10852253006028PVS Dental Impression Material

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