Set 8805001

GUDID DO3688050011

SDI LIMITED

Dental composite resin
Primary Device IDDO3688050011
NIH Device Record Key577ddc51-800e-4dde-8b0b-ec666d3e8ae6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSet
Version Model NumberSET A1 50 CAP
Catalog Number8805001
Company DUNS753221852
Company NameSDI LIMITED
Device Count50
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 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3688050010 [Unit of Use]
HIBCCDO3688050011 [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 [Set]

DO3688100001SET ASSORTED KT
DO3688050031SET OA3 50 CAP
DO3688050021SET A2 50 CAP
DO3688050011SET A1 50 CAP

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