RIVA BOND 8800610

GUDID DO3688006101

SDI LIMITED

Glass ionomer dental cement
Primary Device IDDO3688006101
NIH Device Record Key0dcd80b1-a7e4-461d-bcf4-0bee0688bcba
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVA BOND
Version Model NumberRIVA BOND LC P/L KT
Catalog Number8800610
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 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3688006101 [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 Date2016-10-10

On-Brand Devices [RIVA BOND]

DO3688006121RIVA BOND LC LQD REF
DO3688006111RIVA BOND LC PWD REF 5G
DO3688006101RIVA BOND LC P/L KT

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