Harmony Posterior Disposable Dual Arch Try

GUDID 00850211006090

Posterior Dual Arch Impression Tray for Dental Use Disposable, Rigid 50/box

HO DENTAL COMPANY LLC

Dental impression tray, single-use
Primary Device ID00850211006090
NIH Device Record Key6a224e2c-afcc-46c1-89d1-3f84636484f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmony Posterior Disposable Dual Arch Try
Version Model NumberPosterior
Company DUNS012676012
Company NameHO DENTAL COMPANY LLC
Device Count50
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850211006090 [Primary]
GS100850211006472 [Unit of Use]

FDA Product Code

EHYTray, Impression, Preformed

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 Date2017-10-10

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