INT, FirstWire

GUDID 16950900919104

Shanghai Kindly Medical Instruments Co., Ltd.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 16950900919104
• NIH Device Record Key: a5da4acd-9265-4fd6-8ce8-2289ca4017ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT, FirstWire
• Version Model Number: GW282AF
• Company DUNS: 420827639
• Company Name: Shanghai Kindly Medical Instruments Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950900919107 [Primary]
GS1	16950900919104 [Package]; Contains: 06950900919107; Package: box [10 Units]; In Commercial Distribution
GS1	26950900919101 [Package]; Contains: 06950900919107; Package: box [40 Units]; In Commercial Distribution
GS1	46950900919105 [Package]; Contains: 06950900919107; Package: carton [160 Units]; In Commercial Distribution
GS1	56950900919102 [Package]; Contains: 06950900919107; Package: carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180177

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

On-Brand Devices [INT, FirstWire]

• 16950900961035: 0.028”*180 cm, PTFE coating, J tip
• 16950900958769: 0.025"*260 cm, PTFE coating, J tip
• 16950900958752: 0.025"*180 cm, PTFE coating, J tip
• 16950900958721: 0.025"*260 cm, PTFE coating, angled tip
• 16950900958714: 0.025"*180 cm, PTFE coating, angled tip
• 16950900958684: 0.025"*260 cm, PTFE coating, straight tip
• 16950900958677: 0.025"*180 cm, PTFE coating, straight tip
• 16950900919142: GW283SF
• 16950900919135: 0.028”*260 cm, PTFE coating, J tip
• 16950900919111: 0.028”*180 cm, PTFE coating, straight tip
• 26950900998656: 0.035"*75cm, PTFE coating, straight tip
• 26950900998649: 0.035"*70cm, PTFE coating, J tip
• 26950900998632: 0.035"*70cm, PTFE coating, Angled tip
• 26950900998625: 0.035"*70cm, PTFE coating, straight tip
• 26950900998618: GW325JF
• 26950900998601: GW325AF
• 26950900998595: GW325SF
• 26950900998588: GW324JF
• 26950900998571: GW324AF
• 26950900998557: GW285JF
• 26950900998540: GW285AF
• 26950900998533: GW285SF
• 26950900998526: GW284JF
• 16950900961523: 0.035"*260cm, PTFE coating,1.5mm J tip
• 16950900961516: 0.035"*180cm, PTFE coating,1.5mm J tip
• 16950900961509: 0.035"*150cm, PTFE coating,1.5mm J tip
• 16950900959926: 0.038"*180cm, PTFE coating, angled tip
• 16950900959902: 0.035"*180cm, PTFE coating, angled tip
• 16950900959889: 0.038"*260cm, PTFE coating, angled tip
• 16950900959872: 0.035"*260cm, PTFE coating, angled tip
• 16950900957571: 0.032"*260cm, PTFE coating, straight tip
• 16950900957564: 0.032"*180cm, PTFE coating, straight tip
• 16950900957540: 0.032"*260cm, PTFE coating, J tip
• 16950900957533: 0.032"*180cm, PTFE coating, J tip
• 16950900957519: 0.038"*260cm, PTFE coating, straight tip
• 16950900926089: 0.035"*260cm, PTFE coating, straight tip
• 16950900923095: 0.038"*180cm, PTFE coating, straight tip
• 16950900923088: 0.035"*180cm, PTFE coating, straight tip
• 16950900921992: 0.038"*180cm, PTFE coating, J tip