FDA.reportPublic FDA data

Sunmed™ guide wires

Primary DI
06947358535454
Brand
Sunmed™ guide wires
Company
Sunny Medical Device (Shenzhen) Co., Ltd.
Model
J-tip, 0.035"x145cm, 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
06947358535454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06947358535454069473585354546947358535454

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
06947358524021Sunmed™ guide wiresJ-tip, 0.035"x200cm, 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
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
00816349014994CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015007CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015014CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015021CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015038CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015045CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015052CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015069CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015076CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25
00816349012587Safari2Lake Region MedicalDQX2026-06-25
00816349012594Safari2Lake Region MedicalDQX2026-06-25
00816349013676WallStentLake Region MedicalDQX2026-06-25
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30