Set PP 8805101

GUDID DO3688051011

SDI LIMITED

Dental composite resin
Primary Device IDDO3688051011
NIH Device Record Key8a607c06-d749-497a-af7f-b3b8f07cc0bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSet PP
Version Model NumberSET PP A1 SYR 2 PK
Catalog Number8805101
Company DUNS753221852
Company NameSDI LIMITED
Device Count2
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
HIBCCDO3688051010 [Unit of Use]
HIBCCDO3688051011 [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 PP]

DO3688100061SET PP ENDO TIPS
DO3688100051SET PP INTRA-ORAL TIPS
DO3688100041SET PP MIXING TIPS (WIDE)
DO3688100031SET PP MIXING TIPS (REGULAR)
DO3688100021SET PP ASSTD 5 SYR
DO3688051051SET PP TRANSLUCENT SYR 2 PK
DO3688051041SET PP WHT/OPQ SYR 2 PK
DO3688051031SET PP OA3 SYR 2 PK
DO3688051021SET PP A2 SYR 2 PK
DO3688051011SET PP A1 SYR 2 PK

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