GS80 4403404

GUDID DO3644034042

SDI LIMITED

Dental amalgam alloy
Primary Device IDDO3644034042
NIH Device Record Key63445397-d9fb-4341-9dc1-77928645e492
Commercial Distribution StatusIn Commercial Distribution
Brand NameGS80
Version Model NumberGS80 3SP SLOW 50
Catalog Number4403404
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 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3644034040 [Unit of Use]
HIBCCDO3644034042 [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 [GS80]

DO3644603032GS80 ALLOY REG 5OZ
DO3644503032GS80 TABS REG 5OZ
DO3644250002GS80 5SP REG 500
DO3644234042GS80 3SP SLOW 500
DO3644233032GS80 3SP REG 500
DO3644232022GS80 3SP FAST 500
DO3644224042GS80 2SP SLOW 500
DO3644223032GS80 2SP REG 500
DO3644222022GS80 2SP FAST 500
DO3644214042GS80 1SP SLOW 500
DO3644213032GS80 1SP REG 500
DO3644212022GS80 1SP FAST 500
DO3644050002GS80 5SP REG 50
DO3644034042GS80 3SP SLOW 50
DO3644033032GS80 3SP REG 50
DO3644032022GS80 3SP FAST 50
DO3644024042GS80 2SP SLOW 50
DO3644023032GS80 2SP REG 50
DO3644022022GS80 2SP FAST 50
DO3644014042GS80 1SP SLOW 50
DO3644013032GS80 1SP REG 50
DO3644012022GS80 1SP FAST 50

Trademark Results [GS80]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GS80
GS80
78554335 3604317 Dead/Cancelled
Greer Industries, Inc.
2005-01-26
GS80
GS80
74649255 not registered Dead/Abandoned
PRIMWELL INVESTMENT PTE. LTD.
1995-03-20

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