FDA.reportPublic FDA data

Sunmed™ guide wires

Primary DI
06947358524021
Brand
Sunmed™ guide wires
Company
Sunny Medical Device (Shenzhen) Co., Ltd.
Model
J-tip, 0.035"x200cm, PTFE Coated
Published
2026-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120119000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120119000SUNMED GUIDE WIRESunny Medical Device (Shenzhen) Co., Ltd.2012-05-11DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06947358524021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947358524021069473585240216947358524021

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Regulatory Flags#

DUNS number
529639795
Device count
1
DM exempt
false
Premarket exempt
false
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
06947358535454Sunmed™ guide wiresJ-tip, 0.035"x145cm, PTFE Coated2026-07-07
06947358535539Sunmed™ guide wires"S-tip, 0.035""x145cm, Hydrophilic Coated"2024-01-05
06947358563402Sunmed Inflation devicesS-type, 30ml, 40atm/bar2023-09-25
06947358546719Sunmed Haemostatic Valves7F, Push-pull, Sideon Tubing and Stopcock, Inserti2023-07-06
06947358571698Sunmed disposable needles18G, Ultra-thin Wall, 7cm, Large Hub2023-07-06
06947358582618Sunmed disposable angio-closure padsLarge Size2023-07-06
06947358544302Sunmed guidewire torque deviceplastic type, white2022-01-04
06947358566007Sunmed Inflation DeviceJ Type, 28ml, 30atm/bar2022-01-04
06947358568001Sunmed Inflation DeviceJ Type, 28ml, 40atm/bar2022-01-04
06947358535317Sunmed Guide WiresJ tip, 0.035in, 175cm2021-12-13
06947358535508Sunmed Guide WiresS tip, 0.035in, 145cm2021-12-13
06947358535713Sunmed Guide WiresJ tip, 0.035in, 150cm2021-12-13
06947358535751Sunmed Guide WiresS tip, 0.035in, 150cm2021-12-13
06947358535812Sunmed Guide WiresJ tip, 0.035in, 260cm2021-12-13
06947358535843Sunmed Guide WiresS tip, 0.035in, 260cm2021-12-13
06947358561507Sunmed Inflation Device20ml, 30atm2021-06-01
06947358520405Sunmed High Pressure Line400psi, 15cm2020-04-15
06947358551904Sunmed Manifold and Stopcocks500psi, off hand2020-04-15
06947358563006Sunmed Inflation Device30atm, 30ml2020-04-15
06947358500001Sunmed Protective face shield340mm×220mm2020-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07