FDA.reportPublic FDA data

Curaway

Primary DI
06936666566731
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
GW-QS 20-77
Device description
Breast Lesion Localization Wire
Published
2026-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
16936666566738PackageGS110In Commercial Distribution
26936666566735PackageGS19In Commercial Distribution
06936666566731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693666656673816936666566738
2693666656673526936666566735
06936666566731069366665667316936666566731

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Regulatory Flags#

DUNS number
412923111
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937278653598CurawayGW-Q 18-1502026-08-22
06937278653604CurawayGW-Q 18-1402026-08-22
06937278653611CurawayGW-Q 18-1202026-08-22
06937278653628CurawayGW-Q 20-1402026-08-22
06937278654250CurawayGW-J 19-502026-08-22
06937278654267CurawayGW-J 19-302026-08-22
06937278654281CurawayGW-QS 20-1402026-08-22
06937278654304CurawayGW-J 18-1202026-08-22
06937278654748CurawayGW-QS 18-1502026-08-22
06937278654755CurawayGW-QS 18-1402026-08-22
06937278654762CurawayGW-J 18-1572026-08-22
06937278654779CurawayGW-J 18-1272026-08-22
06937278654786CurawayGW-J 18-1502026-08-22
06937278654823CurawayGW-Y 20-772026-08-22
06937278654830CurawayGW-Y 20-1072026-08-22
06937278654847CurawayGW-J 20-1402026-08-22
06937278654854CurawayGW-J 19-702026-08-22
06937278654861CurawayGW-J 19-902026-08-22
06937278654878CurawayGW-J 19-1402026-08-22
06937278654885CurawayGW-J 19-372026-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982350633VOLTSynthes GmbHFZX2026-09-25
10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
10886982350664VOLTSynthes GmbHFZX2026-09-25
10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
00810111228527Drill GuideTreace Medical Concepts, Inc.FZX2026-09-21
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