FDA.reportPublic FDA data

Curaway

Primary DI
06937278653321
Brand
Curaway
Company
Zhejiang CuraWay Medical Technology Co., Ltd.
Model
GW-Q 20-77
Device description
Breast Lesion Localization Wire
Published
2026-08-15
Public version status
New
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
16937278653328PackageGS110In Commercial Distribution
26937278653325PackageGS19In Commercial Distribution
06937278653321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693727865332816937278653328
2693727865332526937278653325
06937278653321069372786533216937278653321

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 radiographic film or digital 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.

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
06936666566724CurawayGW-QS 20-1072026-08-15
06936666566731CurawayGW-QS 20-772026-08-15
06937278634917CurawayBN-MAR-4/16152026-08-15
06937278634924CurawayBN-MAR-4/16202026-08-15
06937278634931CurawayBN-MAR-4/16252026-08-15
06937278634962CurawayBN-MAR-4/18152026-08-15
06937278634979CurawayBN-MAR-4/18202026-08-15
06937278634986CurawayBN-MAR-4/18252026-08-15
06937278635013CurawayBN-MAR-4/19152026-08-15
06937278635020CurawayBN-MAR-4/19202026-08-15
06937278635037CurawayBN-MAR-4/19252026-08-15
06937278635068CurawayBN-MAR-4/20152026-08-15
06937278635075CurawayBN-MAR-4/20202026-08-15
06937278635082CurawayBN-MAR-4/20252026-08-15
06937278635112CurawayBN-MAR-4/21152026-08-15
06937278635129CurawayBN-MAR-4/21202026-08-15
06937278635136CurawayBN-MAR-4/21252026-08-15
06937278635167CurawayBN-MAR-4/22152026-08-15
06937278635174CurawayBN-MAR-4/22202026-08-15
06937278635181CurawayBN-MAR-4/22252026-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121657Working Tube with long lipJoimax GmbHFZX2026-08-19
00810111225465joint seekerTreace Medical Concepts, Inc.FZX2026-08-17
06936666566724CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06936666566731CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653161CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653475CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278653499CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654793CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
06937278654809CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-15
00810111225427TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00810111225434TargeterTreace Medical Concepts, Inc.FZX2026-08-14
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
00840606191838Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00840606191845Overwatch PCFSPINAL ELEMENTS, INC.FZX2026-07-31
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089542548AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543378AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543682AMPLITUDEAMPLITUDE SASFZX2026-07-29
03700569674335Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24