SciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive 60-051

GUDID D801SP60051B1

CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Introductory Kit. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dentine adhesive Dentine adhesive
Primary Device IDD801SP60051B1
NIH Device Record Key541015b0-1f3b-47ab-91b2-7a76b4c24913
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm CuRay Eclipse Visible Light-Cured Orthodontic Adhesive
Version Model NumberSP 60-051 B
Catalog Number60-051
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, 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 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
HIBCCD801SP60051B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

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 Date2016-08-10

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