RIVA PROTECT 8680000

GUDID DO3686800001

SDI LIMITED

Glass ionomer dental cement
Primary Device IDDO3686800001
NIH Device Record Key977c4ef6-e5ac-4881-8364-50974f4679aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA PROTECT
Version Model NumberRIVA PROTECT PINK 50 CAP
Catalog Number8680000
Company DUNS753221852
Company NameSDI LIMITED
Device Count50
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

Phone+18002285166
Emailinfo@sdi.com.au

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3686800000 [Unit of Use]
HIBCCDO3686800001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSEALANT, PIT AND FISSURE, AND CONDITIONER

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 Date2016-10-07

On-Brand Devices [RIVA PROTECT]

DO3686950001RIVA PROTECT WHT 50 CAP FAST
DO3686905011RIVA PROTECT P/L WHITE
DO3686901011RIVA PROTECT PWD REF WHITE
DO3686900001RIVA PROTECT WHITE 50 CAP
DO3686850001RIVA PROTECT PINK 50 CAP FAST
DO3686809001RIVA PROTECT LQD REF
DO3686805011RIVA PROTECT P/L PINK
DO3686801011RIVA PROTECT PWD REF PINK
DO3686800001RIVA PROTECT PINK 50 CAP

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