Niti-S Colonic Comfort Stent

GUDID 08809909414381

The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, flexible Stent Delivery System for placement of the stent.

TAEWOONGMEDICAL.CO.,LTD

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• Primary Device ID: 08809909414381
• NIH Device Record Key: 15b9b817-61cb-41b0-8e29-af0c2e114768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Niti-S Colonic Comfort Stent
• Version Model Number: CDT2210N-22
• Company DUNS: 689484322
• Company Name: TAEWOONGMEDICAL.CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com
• Phone: 323-692-0028
• Email: minsoo@taewoongusa.com

Device Dimensions

• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter
• Stent Diameter: 22 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Length: 100 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809909414381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223067

FDA Product Code

• MQR: Stent, Colonic, Metallic, Expandable

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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [Niti-S Colonic Comfort Stent]

• 08809909414435: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414428: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414411: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414404: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414398: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414381: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414374: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414367: The Niti-S Colonic Comfort Stent consists of an implantable metallic stent and a disposable, fle