FDA.reportPublic FDA data

TRUEFORM KEYHOLE

Primary DI
10190886174548
Brand
TRUEFORM KEYHOLE
Company
G & H Wire Company, Inc.
Model
KHTFK41925A
Device description
SS TFI KEYHOLE 4 LOOP KIT 019x025
Published
2025-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190886174548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019088617454810190886174548

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.019Inch
Width0.025Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(317)346-6655orders@ghortho.com

Regulatory Flags#

DUNS number
831465641
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190886271612G&H ORTHODONTICS ®131-L5-8RK-V2026-02-27
10190886271629G&H ORTHODONTICS ®131-L5-8LK-V2026-02-27
10190886271841G&H ORTHODONTICS ®131-L5-2RK-V2026-02-27
10190886271858G&H ORTHODONTICS ®131-L5-2LK-V2026-02-27
10190886271025G&H ORTHODONTICS ®130-U1-8R-V2026-02-27
10190886271032G&H ORTHODONTICS ®130-U1-8L-V2026-02-27
10190886271049G&H ORTHODONTICS ®130-U2-8R-V2026-02-27
10190886271056G&H ORTHODONTICS ®130-U2-8L-V2026-02-27
10190886271063G&H ORTHODONTICS ®130-U3-8RK-V2026-02-27
10190886271070G&H ORTHODONTICS ®130-U3-8LK-V2026-02-27
10190886271087G&H ORTHODONTICS ®130-U4-8RK-V2026-02-27
10190886271094G&H ORTHODONTICS ®130-U4-8LK-V2026-02-27
10190886271100G&H ORTHODONTICS ®130-U4-8U-V2026-02-27
10190886271117G&H ORTHODONTICS ®130-L1-8U-V2026-02-27
10190886271124G&H ORTHODONTICS ®130-L3-8RK-V2026-02-27
10190886271131G&H ORTHODONTICS ®130-L3-8LK-V2026-02-27
10190886271148G&H ORTHODONTICS ®130-L4-8U-V2026-02-27
10190886271155G&H ORTHODONTICS ®130-L4-8RK-V2026-02-27
10190886271162G&H ORTHODONTICS ®130-L4-8LK-V2026-02-27
10190886271179G&H ORTHODONTICS ®130-L5-8U-V2026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611211736LINGUAL RETAINER STRAIGHT WIRES - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611212641LINGUAL RETAINER CHAIN - SOFT - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611213853LINGUAL RETAINER CHAIN - HARD - 1 METERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2026-01-12
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2025-04-02
07899439270497ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270503ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439270510ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439272583ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07899439292949ADITEKADITEK DO BRASIL S/ADZC2025-01-17
07908611210029"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210036"PROMO KIT ADVANCED ROTH 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210043"PROMO KIT ADVANCED MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07908611210050"PROMO KIT ADVANCED MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZC2024-04-16
07895742151591MorelliDental Morelli LtdaDZC2021-04-30
07895742161194MorelliDental Morelli LtdaDZC2021-04-30
07895742161200MorelliDental Morelli LtdaDZC2021-04-30
07895742161217MorelliDental Morelli LtdaDZC2021-04-30
07895742161224MorelliDental Morelli LtdaDZC2021-04-30
07895742161231MorelliDental Morelli LtdaDZC2021-04-30
07895742161248MorelliDental Morelli LtdaDZC2021-04-30
07895742161255MorelliDental Morelli LtdaDZC2021-04-30
07895742161262MorelliDental Morelli LtdaDZC2021-04-30