FDA.reportPublic FDA data

gSource

Primary DI
M7558210500
Brand
gSource
Company
GSOURCE LLC
Model
gS 82.1050
Catalog number
gS 82.1050
Device description
Seven Step Wire Bender 5 1/2" max cap 0.5mm [.0195"] wire
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
EJYPliers, Operative
HXPInstrument, Bending Or Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJYPliers, OperativeDental1
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7558210500PrimaryHIBCC0

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
G149TBSB2140TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3070TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3080TBS BASICSACME ENTERPRISE.EJY2026-05-16
G149TBSB3090TBS BASICSACME ENTERPRISE.EJY2026-05-16
03700569620479Newclip InstrumentsNEWCLIP TECHNICSHXP2026-05-07
00840311262960Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXP2026-04-27
00199150066919Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-03-02
07640187463149Bending Iron SmallBonebridge AGHXP2026-01-16
07640187463156Bending Plier SmallBonebridge AGHXP2026-01-16
07640187463163Cutting PlierBonebridge AGHXP2026-01-16
00199150029464Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-10-19
M711CI1310Opteryx®INNO Holdings, Inc.HXP2025-06-30
08800071031833SignexOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697369Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809416068626Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-25
08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
07898588840032PEAK 003ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840049PEAK 004ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840841121ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588840902ELASTIC SETTERZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841244REPLACEMENTZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841497TRIDENT CURTO MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841541TWEED OMEGA LOOP MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841602V BEND MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841657WEINGART MINIZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588841855117 PZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
07898588842272117 IZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-03-07
00763000987336Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-02-28
07898588840223CONVENTIONAL LARGE LINGUALZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDAEJY2025-02-25