RIVA SC 8610102

GUDID DO3686101021

SDI LIMITED

Glass ionomer dental cement
Primary Device IDDO3686101021
NIH Device Record Keyeac18200-ab54-44bb-aa54-14c348816ee7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA SC
Version Model NumberRIVA SC A2 PWD REF 15G
Catalog Number8610102
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 Kitfalse
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
HIBCCDO3686101021 [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 Date2016-09-30

On-Brand Devices [RIVA SC]

DO3686300041RIVA SC HV A3.5 50 CAP
DO3686300031RIVA SC HV A3 50 CAP
DO3686300021RIVA SC HV A2 50 CAP
DO3686300011RIVA SC HV A1 50 CAP
DO3686200071RIVA SC STARTER FAST KT A2
DO3686200061RIVA SC STARTER FAST KT A1
DO3686200051RIVA SC STARTER REG KT A2
DO3686200041RIVA SC STARTER REG KT A1
DO3686200001RIVA SC CAP FAST ASSTD KT
DO3686105231RIVA SC T-A3.5 P/L KT REG 15G
DO3686105221RIVA SC T-A3 P/L KT REG 15G
DO3686105211RIVA SC T-A2 P/L KT REG 15G
DO3686105081RIVA SC B3 P/L KT
DO3686105071RIVA SC B2 P/L KT
DO3686105051RIVA SC A4 P/L KT
DO3686105041RIVA SC A3.5 P/L KT
DO3686105031RIVA SC A3 P/L KT
DO3686105021RIVA SC A2 P/L KT
DO3686105011RIVA SC A1 P/L KT
DO3686101081RIVA SC B3 PWD REF 15G
DO3686101051RIVA SC A4 PWD REF 15G
DO3686101031RIVA SC A3 PWD REF 15G
DO3686101021RIVA SC A2 PWD REF 15G
DO3686101011RIVA SC A1 PWD REF 15G
DO3686100001RIVA SC CAP REG ASSTD KT
DO3686050081RIVA SC B3 FAST 50 CAP
DO3686050071RIVA SC B2 FAST 50 CAP
DO3686050051RIVA SC A4 FAST 50 CAP
DO3686050041RIVA SC A3.5 FAST 50 CAP
DO3686050031RIVA SC A3 FAST 50 CAP
DO3686050021RIVA SC A2 FAST 50 CAP
DO3686050011RIVA SC A1 FAST 50 CAP
DO3686000131RIVA SC T-A3.5 FAST 50 CAP
DO3686000121RIVA SC T-A3 FAST 50 CAP
DO3686000111RIVA SC T-A2 FAST 50 CAP
DO3686000081RIVA SC B3 REG 50 CAP
DO3686000071RIVA SC B2 REG 50 CAP
DO3686000051RIVA SC A4 REG 50 CAP
DO3686000041RIVA SC A3.5 REG 50 CAP
DO3686000031RIVA SC A3 REG 50 CAP
DO3686000021RIVA SC A2 REG 50 CAP
DO3686000011RIVA SC A1 REG 50 CAP

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