Perfectim Putty Type Kit

GUDID 00852253006090

PVS Dental Impression Material

J. MORITA U.S.A., INC

Silicone dental impression material
Primary Device ID00852253006090
NIH Device Record Key0944de65-2bfb-4520-a3c4-d5eda83a995c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerfectim Putty Type Kit
Version Model Number21300050
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
GS100852253006090 [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

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