INITIALLOY 71-C3U0-0018

GUDID D78871C3U000180

INITIALLOY FORM C 018 U HEAVY

Gc Orthodontics America Inc.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire
Primary Device IDD78871C3U000180
NIH Device Record Key66800488-b226-4ddf-bf77-e38a84c71cc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameINITIALLOY
Version Model Number71-C3U0-0018
Catalog Number71-C3U0-0018
Company DUNS063167128
Company NameGc Orthodontics America Inc.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com
Phone+1(708)897-8859
EmailGCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000180 [Unit of Use]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]
HIBCCD78871C3U000181 [Primary]

FDA Product Code

DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC
DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [INITIALLOY]

D78879ACU420200INITIALLOY FORM C 018 U HEAVY
D78871C3U000180INITIALLOY FORM C 018 U HEAVY
D78871C3U000140INITIALLOY FORM C 014 U HEAVY
D78871C3L000180INITIALLOY FORM C 018 L HEAVY
D78871C3L000140INITIALLOY FORM C 014 HEAVY

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.