FDA.reportPublic FDA data

P01-01

Primary DI
08800046045896
Brand
P01-01
Company
GNI Co.,Ltd
Model
P01-01
Published
2024-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEXPlier, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800046045896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800046045896088000460458968800046045896

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic pliersA hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694828541
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800046051484SS650SS6502025-04-04
08800046051309SSBC-M22-464GSSBC-M22-464G2024-06-18
08800046051316SSBC-M22-364GSSBC-M22-364G2024-06-18
08800046051323SSBC-M22-264GSSBC-M22-264G2024-06-18
08800046051330SSBC-M22-164GSSBC-M22-164G2024-06-18
08800046051385SSBC-M22-1M44GSSBC-M22-1M44G2024-06-18
08800046027540IES1-1001IES1-10012024-06-04
08800046046602SN02-1018SN02-10182024-06-04
08800046050357ELT-01ELT-012024-06-04
08800046000642SA1208CSA1208C2022-12-13
08800046000659SA1210CSA1210C2022-12-13
08800046000666SA1406CSA1406C2022-12-13
08800046000673SA1408CSA1408C2022-12-13
08800046000680SA1410CSA1410C2022-12-13
08800046000697SA1606CSA1606C2022-12-13
08800046000703SA1608CSA1608C2022-12-13
08800046000710SA1610CSA1610C2022-12-13
08800046000727SA1806CSA1806C2022-12-13
08800046000734SA1808CSA1808C2022-12-13
08800046000741SA1810CSA1810C2022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898488905107WEINGART PLIER W/OUT WIDIAORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488907217TUBE CONVERSION PLIER – 4003ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07898488909945ELASTIC LIGATURE APPLICATOR/REMOVERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705735PLIER ANGLE W/ WIDIA AND CUTTING (139)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908470705803TORQUE PLIER SHORT (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611200129PLIER FOR LONG TORQUE (442)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611204325ANGULAR BRACKET REMOVAL PLIERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2026-05-27
07908611210074"PROMO KIT ICERAM-P MBT 0.022"""ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAJEX2024-04-16
07898506853069QuinelatoSchobell Industrial LtdaJEX2023-01-10
07898506814039QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506814244QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506841318QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506848669QuinelatoSchobell Industrial LtdaJEX2022-12-16
07898506850228QuinelatoSchobell Industrial LtdaJEX2022-12-16
07895742204273MorelliDental Morelli LtdaJEX2021-04-30
ESAM6005001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6011001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6015001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6026001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6028001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6030001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6034001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6045001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6047001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6071001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6073131STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6075001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6078001STOMA®Storz am Mark GmbHJEX2020-08-27
ESAM6080001STOMA®Storz am Mark GmbHJEX2020-08-27
08033707076841LEONE SPALEONE SPAJEX2020-05-11