FDA.reportPublic FDA data

Stainless Steel Guide Wires

Primary DI
00840194465588
Brand
Stainless Steel Guide Wires
Company
ORTHOPEDIATRICS CORP.
Model
01-9473-6007
Catalog number
01-9473-6007
Device description
2.0mm x 75mm Guide Wire, Smooth
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194465588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194465588008401944655888401944655880840194465588

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, single-useA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
796416191
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
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840536800244Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
00840536800251Response 5.5/6.0ORTHOPEDIATRICS CORP.KIJ2026-03-03
07901125600706Minidriver SolarisGM DOS REIS INDUSTRIA E COMERCIO LTDAKIJ2026-02-20
07649988202209FiberLocker PowerUnit - Transfer ShieldZuriMED Technologies AGKIJ2026-02-02
07649988202278FiberLocker PowerUnit - HandpieceZuriMED Technologies AGKIJ2026-02-02
07649988202285FiberLocker PowerUnit - Motor PackZuriMED Technologies AGKIJ2026-02-02
07649988202292FiberLocker PowerUnit - Charging StationZuriMED Technologies AGKIJ2026-02-02
08800038060319EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060326EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060333EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
08800038060340EZImpactorIMEDICOM CO., LTD.KIJ2026-01-22
00850056900102Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
08800068959348LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959355LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800068959645LOSPA Surgical InstrumentsCorentec Co., LtdKIJ2025-11-25
08800017270258BENCOX Surgical InstrumentsCorentec Co., LtdKIJ2025-09-24
08809260475052TD-AUTOSaeshin Precision Co., Ltd.KIJ2025-07-22
008401944934513P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937723P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944937893P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008401944938883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863123P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321863293P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19
008411321866883P Hip SystemORTHOPEDIATRICS CORP.KIJ2025-06-19