RIVA CONDITIONER 8620001

GUDID DO3686200011

SDI LIMITED

Dental pit/fissure sealant
Primary Device IDDO3686200011
NIH Device Record Keyb9bc0f61-1925-478d-9fd8-dd44f33cfb16
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA CONDITIONER
Version Model NumberRIVA CONDITIONER 10ML PK
Catalog Number8620001
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 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3686200011 [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 Date2016-09-30

Devices Manufactured by SDI LIMITED

DO3684520041 - LUNA 22024-02-16
DO3684520251 - LUNA 22024-02-16
DO3686400011 - STELA2024-02-16
DO3686400021 - STELA2024-02-16
DO3686400031 - STELA2024-02-16
DO3686400041 - STELA2024-02-16
DO3686400061 - STELA2024-02-16
DO3685600011 - AURA2019-12-16

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