Maxima Radiopaque Kit 2283013

GUDID 10304040000868

Maxima Radiopaque Kit

HENRY SCHEIN, INC.

Resin artificial teeth
Primary Device ID10304040000868
NIH Device Record Key850585ba-d6c4-4344-8cde-058c3c6378d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMaxima Radiopaque Kit
Version Model Number2283013
Catalog Number2283013
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 Kittrue
Device Combination Producttrue
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
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Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Storage this product in a cool and dry area
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040000861 [Primary]
GS110304040000868 [Package]
Contains: 00304040000861
Package: KIT [13 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by HENRY SCHEIN, INC.

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00304040192481 - Henry Schein2025-07-07
00304040192405 - Henry Schein2025-07-04 EKG Paper Single Channel HSI, BURDICK 7989
00304040192412 - Henry Schein2025-07-04 EKG Paper Multi Channel HSI, BURDICK 7868
00304040192429 - Henry Schein2025-07-04 EKG Paper Z-Fold HSI Red Grid, MARQUETTE 9402-024
00304040192436 - Henry Schein2025-07-04 EKG Paper for AT-2 8.2x11 HSI, SCHILLER 2157-017

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