G4 EUROPA NICKEL TITANIUM SOLO-PACK

GUDID 20190886021986

G4 EFII PTORQ 016x025 UNIV 28MM SOLO

G & H Wire Company, Inc.

Orthodontic archwire
Primary Device ID20190886021986
NIH Device Record Key3209df53-54e6-439b-a670-3f66617e6257
Commercial Distribution StatusIn Commercial Distribution
Brand NameG4 EUROPA NICKEL TITANIUM SOLO-PACK
Version Model NumberPTEF362528S
Company DUNS831465641
Company NameG & H Wire Company, Inc.
Device Count1
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com

Device Dimensions

Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch
Width0.025 Inch
Height0.016 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS110190886021989 [Primary]
GS120190886021986 [Package]
Contains: 10190886021989
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DZCWIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-04
Device Publish Date2025-03-27

On-Brand Devices [G4 EUROPA NICKEL TITANIUM SOLO-PACK]

20190886242770G4 NITI EFII UPR 018x025 SOLO-PACK
20190886242763G4 NITI EFII UPR 018x025 W/STOPS SOLO-PACK
20190886242756G4 NITI EFII UPR 018x018 W/STOPS SOLO-PACK
20190886242749G4 NITI EFII UPR 017x025 SOLO-PACK
20190886242732G4 NITI EFII UPR 017x025 DIMPLED SOLO-PACK
20190886242725G4 NITI EFII UPR 017x025 W/STOPS SOLO-PACK
20190886242718G4 NITI EFII UPR 017x017 W/STOPS SOLO-PACK
20190886242701G4 NITI EFII UPR 016x025 SOLO-PACK
20190886242695G4 NITI EFII UPR 016x022 SOLO-PACK
20190886242688G4 NITI EFII UPR 016x022 DIMPLED SOLO-PACK
20190886242671G4 NITI EFII UPR 016x022 W/STOPS SOLO-PACK
20190886242664G4 NITI EFII UPR 016x016 SOLO-PACK
20190886242657G4 NITI EFII UPR 016x016 W/STOPS SOLO-PACK
20190886242640G4 NITI EFII UPR 014x025 SOLO-PACK
20190886242633G4 NITI EFII UPR 014x025 W/STOPS SOLO-PACK
20190886242626G4 NITI EFII UPR 021x025 SOLO-PACK
20190886242619G4 NITI EFI UPR 021x025 SOLO-PACK
20190886242602G4 NITI EFI UPR 020x020 SOLO-PACK
20190886242596G4 NITI EFI UPR 019x025 SOLO-PACK
20190886242589G4 NITI EFI UPR 019x025 DIMPLED SOLO-PACK
20190886242572G4 NITI EFI UPR 019x025 W/STOPS SOLO-PACK
20190886242565G4 NITI EFI UPR 018x025 SOLO-PACK
20190886242558G4 NITI EFI UPR 018x018 SOLO-PACK
20190886242541G4 NITI EFI UPR 017x025 SOLO-PACK
20190886242534G4 NITI EFI UPR 017x025 DIMPLED SOLO-PACK
20190886242527G4 NITI EFI UPR 017x025 W/STOPS SOLO-PACK
20190886242510G4 NITI EFI UPR 016x022 SOLO-PACK
20190886242503G4 NITI EFI UPR 016x022 DIMPLED SOLO-PACK
20190886242497G4 NITI EFI UPR 016x022 W/STOPS SOLO-PACK
20190886242480G4 NITI EFI UPR 016x016 SOLO-PACK
20190886242473G4 NITI EFI UPR 014x025 SOLO-PACK
20190886242466G4 NITI EFII UPR 020 SOLO-PACK
20190886242459G4 NITI EFII UPR 020 DIMPLED SOLO-PACK
20190886242442G4 NITI EFII UPR 018 SOLO-PACK
20190886242435G4 NITI EFII UPR 018 W/STOPS SOLO-PACK
20190886242428G4 NITI EFII UPR 016 SOLO-PACK
20190886242411G4 NITI EFII UPR 016 DIMPLED SOLO-PACK
20190886242404G4 NITI EFII UPR 016 W/STOPS SOLO-PACK
20190886242398G4 NITI EFII UPR 014 SOLO-PACK
20190886242381G4 NITI EFII UPR 014 W/STOPS SOLO-PACK
20190886242374G4 NITI EFII UPR 013 SOLO-PACK
20190886242367G4 NITI EFII UPR 012 SOLO-PACK
20190886242350G4 NITI EFI UPR 020 SOLO-PACK
20190886242343G4 NITI EFI UPR 018 SOLO-PACK
20190886242336G4 NITI EFI UPR 018 DIMPLED SOLO-PACK
20190886242329G4 NITI EFI UPR 018 W/STOPS SOLO-PACK
20190886242312G4 NITI EFI UPR 016 SOLO-PACK
20190886242305G4 NITI EFI UPR 016 DIMPLED SOLO-PACK
20190886242299G4 NITI EFI UPR 016 W/STOPS SOLO-PACK
20190886242282G4 NITI EFI UPR 014 SOLO-PACK
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.