FDA.reportPublic FDA data

General Instrument

Primary DI
00841132125816
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-1003-6293
Catalog number
01-1003-6293
Device description
Rod Wrench
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWRENCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132125816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132125816008411321258168411321258160841132125816

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01
00817867021082PNP Femur00-1560-718000-1560-71802026-10-01
00817867021099PNP Femur00-1560-718500-1560-71852026-10-01
00817867021105PNP Femur00-1560-719000-1560-71902026-10-01
00817867021112PNP Femur00-1560-719500-1560-71952026-10-01
00817867021129PNP Femur00-1560-720000-1560-72002026-10-01
00817867021136PNP Femur00-1560-720500-1560-72052026-10-01
00817867021143PNP Femur00-1560-721000-1560-72102026-10-01
00817867021150PNP Femur00-1560-721500-1560-72152026-10-01
00817867021167PNP Femur00-1560-722000-1560-72202026-10-01
00817867021174PNP Femur00-1560-722500-1560-72252026-10-01
00817867021181PNP Femur00-1560-723000-1560-72302026-10-01
00817867021198PNP Femur00-1560-723500-1560-72352026-10-01
00817867021204PNP Femur00-1560-724000-1560-72402026-10-01
00817867021211PNP Femur00-1560-724500-1560-72452026-10-01
00817867021228PNP Femur00-1560-725000-1560-72502026-10-01
00817867021235PNP Femur00-1560-725500-1560-72552026-10-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03701089540759AMPLITUDEAMPLITUDE SASHXC2026-07-29
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00817247023323MedTorqueArch Medical Solutions Corp.HXC2026-06-30
00817247024559MedTorqueArch Medical Solutions Corp.HXC2026-06-30
B756007053001000Torque WrenchShukla MedicalHXC2026-06-01
10886982362964NASynthes GmbHHXC2026-05-04
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1085007050056915mm CurvaFix Hex Wrench CURVAFIX, INC.HXC2025-10-22
10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
18059015376494ORTHOFIXORTHOFIX SRLHXC2025-03-31
08800104097966Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
08809885799762Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.HXC2025-03-17
08809885799816AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.HXC2025-03-17
18059015376029TRUELOK SYSTEMORTHOFIX SRLHXC2025-01-10
00817247023491MedTorqueArch Medical Solutions Corp.HXC2024-11-08
10840199540805Modified Kaufman Type Kidney ClampKOROS U.S.A., INC.HXC2024-01-31
00841732144309GENERIC Surgical InstrumentsCTL Medical CorporationHXC2023-09-15
08800068966230LOSPA Modular Knee SystemCorentec Co., LtdHXC2022-10-24
08800068964960LOSPA Modular Knee System Corentec Co., LtdHXC2022-10-23
10845854023976ULTRAPOWERConmed CorporationHXC2022-06-02
B07301K0360280Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380000Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380010Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380020Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380030Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
B07301K0380200Kalitec Universal InstrumentsKalitec Direct LLCHXC2019-12-19
10886982195722NASynthes GmbHHXC2019-02-21
08809265159063Surgical InstrumentJeil Medical CorporationHXC2018-11-28