INT,K2 Microcatheter

GUDID 26950900998861

1.6F-2.3F, 110cm, curved tip,fully hydrophilic coating

Shanghai Kindly Medical Instruments Co., Ltd.

Coronary artery infusion catheter

• Primary Device ID: 26950900998861
• NIH Device Record Key: e2d6ca58-c843-487b-a17c-cffcc57fdc2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT,K2 Microcatheter
• Version Model Number: MCM01-0L
• 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	06950900998867 [Primary]
GS1	26950900998861 [Package]; Contains: 06950900998867; Package: box [5 Units]; In Commercial Distribution
GS1	46950900998865 [Package]; Contains: 06950900998867; Package: carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201706

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [INT,K2 Microcatheter]

• 26950900998939: 1.8F-2.5F, 180cm, curved tip,fully hydrophilic coating
• 26950900998922: 1.8F-2.5F, 150cm, curved tip,fully hydrophilic coating
• 26950900998915: 1.8F-2.5F, 130cm, curved tip,fully hydrophilic coating
• 26950900998908: 1.8F-2.5F, 110cm, curved tip,fully hydrophilic coating
• 26950900998892: 1.6F-2.3F, 180cm, curved tip,fully hydrophilic coating
• 26950900998885: 1.6F-2.3F, 150cm,, curved tip,fully hydrophilic coating
• 26950900998878: 1.6F-2.3F, 130cm, curved tip,fully hydrophilic coating
• 26950900998861: 1.6F-2.3F, 110cm, curved tip,fully hydrophilic coating
• 26950900998854: 1.8F-2.5F, 180cm, straight tip,fully hydrophilic coating
• 26950900998847: 1.8F-2.5F, 150cm, straight tip,fully hydrophilic coating
• 26950900998830: 1.8F-2.5F, 130cm, straight tip,fully hydrophilic coating
• 26950900998823: 1.8F-2.5F, 110cm, straight tip,fully hydrophilic coating
• 26950900998816: 1.6F-2.3F, 180cm, straight tip,fully hydrophilic coating
• 26950900998809: 1.6F-2.3F, 150cm, straight tip,fully hydrophilic coating
• 26950900998793: 1.6F-2.3F, 130cm, straight tip,fully hydrophilic coating
• 26950900998786: 1.6F-2.3F, 110cm, straight tip,fully hydrophilic coating
• 26950900955802: 1.8F-2.5F, 180cm, curved tip
• 26950900955796: 1.8F-2.5F, 150cm, curved tip
• 26950900955789: 1.8F-2.5F, 130cm, curved tip
• 26950900955772: 1.8F-2.5F, 110cm, curved tip
• 26950900955765: 1.6F-2.3F, 180cm, curved tip
• 26950900955758: 1.6F-2.3F, 150cm,, curved tip
• 26950900955741: 1.6F-2.3F, 130cm, curved tip
• 26950900955734: 1.6F-2.3F, 110cm, curved tip
• 26950900955710: 2.8F-3.0F, 150cm, straight tip
• 26950900955703: 2.8F-3.0F, 130cm, straight tip
• 26950900955604: 1.8F-2.5F, 180cm, straight tip
• 26950900955598: 1.8F-2.5F, 150cm, straight tip
• 26950900955581: 1.8F-2.5F, 110cm, straight tip
• 26950900955574: 1.6F-2.3F, 180cm, straight tip
• 26950900955567: 1.6F-2.3F, 110cm, straight tip
• 26950900934319: 1.6F-2.3F, 150cm, straight tip
• 26950900934289: 1.8F-2.5F, 130cm, straight tip
• 26950900929643: 1.6F-2.3F, 130cm, straight tip