FDA.reportPublic FDA data

Curaway

Primary DI
06937278654779
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
GW-J 18-127
Device description
Breast Lesion Localization Wire
Published
2026-08-22
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
16937278654776PackageGS110In Commercial Distribution
26937278654773PackageGS110In Commercial Distribution
06937278654779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727865477616937278654776
2693727865477326937278654773
06937278654779069372786547796937278654779

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
06937278644121CurawayBN-MAR-6/150402026-06-30
06937278634245CurawayBN-MAR-3/23052026-07-31
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121916Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121923Working Tube with Handle, oblique 35°Joimax GmbHFZX2026-10-22
04250337121930Working Tube with Handle, long lipJoimax GmbHFZX2026-10-22
04250337122029Guiding Rod, conicalJoimax GmbHFZX2026-10-22
04250337122036Guiding Rod, conical, greenJoimax GmbHFZX2026-10-22
00810055071210OviTex®TELA BIO, INC.FZX2026-10-21
00190446960362DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
00190446960379DYNANAIL HELIXMedshape, Inc.FZX2026-10-09
10840143919350AtriClip® Selection GuideATRICURE, INC.FZX2026-10-09
06932503563857Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563864Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
06932503563871Additional Working ChannelMicro-Tech (Nanjing) Co., Ltd.FZX2026-09-30
00810112597462TriLEAPSynthes GmbHFZX2026-02-10
00810112597479TriLEAPSynthes GmbHFZX2026-02-10