Z-Dent Anterior 2285328

GUDID 10304040000875

Z-Dent Anterior

HENRY SCHEIN, INC.

Resin artificial teeth
Primary Device ID10304040000875
NIH Device Record Key4397e9f1-d167-4170-9e9f-172ce89db4f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameZ-Dent Anterior
Version Model Number2285328
Catalog Number2285328
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040000878 [Primary]
GS110304040000875 [Package]
Contains: 00304040000878
Package: BOX [20 Units]
In Commercial Distribution

FDA Product Code

ELMDenture, plastic, teeth

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 Date2016-09-24

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