BIO-ACTIVE 70-A1L0-2218

GUDID D7887A1L022180

BIO-ACTIVE FORM A 22X18 LWR

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 IDD7887A1L022180
NIH Device Record Key4696c672-2f9e-458d-9126-82326ee41d5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIO-ACTIVE
Version Model Number70-A1L0-2218
Catalog Number70-A1L0-2218
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
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD78870A1L022181 [Primary]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]
HIBCCD7887A1L022180 [Unit of Use]

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 [BIO-ACTIVE]

D78874B0U018250BIO-ACTIVE RC U FORM B 18X25
D78870A1U022180BIO-ACTIVWE FORM A 21/18 UPR
D7887A1L022180BIO-ACTIVE FORM A 22X18 LWR

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