SciPharm NeoZoe, Temporary Cement 51-40

GUDID D801SP51401

NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5 mL. Dual Barrel Syringe.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin
Primary Device IDD801SP51401
NIH Device Record Key265c6506-f220-4a48-a2f8-69753fc5b736
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm NeoZoe, Temporary Cement
Version Model NumberSP 51-40
Catalog Number51-40
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, INC.
Device Count1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-634-3047
EmailDenise@scipharm.com
Phone800-634-3047
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP51401 [Primary]

FDA Product Code

EMBZinc Oxide Eugenol

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 Date2016-08-03

On-Brand Devices [SciPharm NeoZoe, Temporary Cement]

D801SP514011NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5
D801SP51401NeoZoe - A Novel Form of Zinc Oxide / Eugenol Temporary Cement in Automix Dispensing System. 5

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