FDA.reportPublic FDA data

Guidewire

Primary DI
00860014213489
Brand
Guidewire
Company
TETROUS, INC.
Model
TET-INS-021
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014213489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014213489008600142134898600142134890860014213489

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111821928
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015151308EnFix Instrument Kit - CompleteTET-KT-0042026-02-24
00860015151315EnFix Instrument Kit - ACLTET-KT-0052026-02-24
00860015151322EnFix Instrument Kit - TACTET-KT-0062026-02-11
00860014213427Awl - Non-CuttingTET-INS-0112026-02-10
00860014213434Cutting Awl - 5.5mmTET-INS-0122026-02-10
00860014213441Cutting Awl - 4.5mmTET-INS-0132026-02-10
00860014213458Introducer ProbeTET-INS-0142026-02-10
00860014213465Instrument TrayTET-INS-0162026-02-10
00860014213472Pusher ProbeTET-INS-0202026-02-10
00860014213496Introducer Probe - SJTET-INS-0072026-02-10
00860014213403Introducer Probe - Flat CollarTET-INS-0052025-11-04
00860014213410Introducer Probe - Stepped CollarTET-INS-0042025-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654281CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654304CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654748CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654755CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654762CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654779CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654786CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654823CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654830CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654847CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654854CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654861CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654878CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654885CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654892CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654908CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22