RIVA LUTING 8651508

GUDID DO3686515081

SDI LIMITED

Glass ionomer dental cement
Primary Device IDDO3686515081
NIH Device Record Key553d20e2-c027-4dde-a083-bbd2bb9dc656
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA LUTING
Version Model NumberRIVA LUTING PLUS P/L KT
Catalog Number8651508
Company DUNS753221852
Company NameSDI LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
HIBCCDO3686515081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACEMENT, DENTAL

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 LUTING]

DO3686519001RIVA LUTING PLUS LQD REF 10G
DO3686515081RIVA LUTING PLUS P/L KT
DO3686511081RIVA LUTING PLUS PWD REF 25G
DO3686510081RIVA LUTING PLUS 50 CAP
DO3686509001RIVA LUTING LQD REF 25G
DO3686505101RIVA LUTING P/L TRIPLE PK
DO3686505081RIVA LUTING P/L KT LARGE
DO3686501081RIVA LUTING LY PWD REF 35
DO3686500081RIVA LUTING LY 50 CAP

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