FDA.reportPublic FDA data

g Source

Primary DI
M7558210200
Brand
g Source
Company
GSOURCE LLC
Model
gS 82.1020
Catalog number
gS 82.1020
Device description
K-Wire and Plate Bender 5 1/2", max cap 1.6mm [.062"]
Published
2020-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
M7558210200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840539702450ExperienceGc Orthodontics America Inc.JEX2026-05-28
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