Image APN Anterior 1215892

GUDID 10304040000929

Image APN Anterior

HENRY SCHEIN, INC.

Resin artificial teeth
Primary Device ID10304040000929
NIH Device Record Key15d3ca77-9ba2-4e99-9652-e5b2d8373f47
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage APN Anterior
Version Model Number1215892
Catalog Number1215892
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
GS100304040000922 [Primary]
GS110304040000929 [Package]
Contains: 00304040000922
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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