INT,FineThrough

GUDID 26950900976210

Shanghai Kindly Medical Instruments Co., Ltd.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 26950900976210
• NIH Device Record Key: 6b7500dc-d675-495e-b69a-e0ccace4c178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT,FineThrough
• Version Model Number: HG144SF
• 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	06950900976216 [Primary]
GS1	16950900976213 [Package]; Contains: 06950900976216; Package: box [5 Units]; In Commercial Distribution
GS1	26950900976210 [Package]; Contains: 06950900976216; Package: box [10 Units]; In Commercial Distribution
GS1	46950900976214 [Package]; Contains: 06950900976216; Package: carton [100 Units]; In Commercial Distribution
GS1	56950900976211 [Package]; Contains: 06950900976216; Package: carton [25 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: 2023-08-29
• Device Publish Date: 2023-08-21

On-Brand Devices [INT,FineThrough]

• 26950900959961: 0.018"*180cm,straight
• 26950900919521: 0.018"*300cm,straight
• 26950900906897: 18 PV-3 x 300 cm
• 26950900906880: 14 PV-3 x 300 cm