LOJIC+ 4221404

GUDID DO3642214042

SDI LIMITED

Dental amalgam alloy
Primary Device IDDO3642214042
NIH Device Record Key4255822e-ba3b-4d02-a711-7fe841799a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOJIC+
Version Model NumberLOJIC+ 1SP SLOW 500
Catalog Number4221404
Company DUNS753221852
Company NameSDI LIMITED
Device Count500
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 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3642214040 [Unit of Use]
HIBCCDO3642214042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, amalgam

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 Date2016-09-23

On-Brand Devices [LOJIC+]

DO3642250002LOJIC+ 5SP REG 500
DO3642234042LOJIC+ 3SP SLOW 500
DO3642233032LOJIC+ 3SP REG 500
DO3642232022LOJIC+ 3SP FAST 500
DO3642224042LOJIC+ 2SP SLOW 500
DO3642223032LOJIC+ 2SP REG 500
DO3642222022LOJIC+ 2SP FAST 500
DO3642214042LOJIC+ 1SP SLOW 500
DO3642213032LOJIC+ 1SP REG 500
DO3642212022LOJIC+ 1SP FAST 500
DO3642050002LOJIC+ 5SP REG 50
DO3642034042LOJIC+ 3SP SLOW 50
DO3642033032LOJIC+ 3SP REG 50
DO3642032022LOJIC+ 3SP FAST 50
DO3642024042LOJIC+ 2SP SLOW 50
DO3642023032LOJIC+ 2SP REG 50
DO3642022022LOJIC+ 2SP FAST 50
DO3642014042LOJIC+ 1SP SLOW 50
DO3642013032LOJIC+ 1SP REG 50
DO3642012022LOJIC+ 1SP FAST 50

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