Niti-S Biliary Speed D Stent

GUDID 08809909414114

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

TAEWOONGMEDICAL.CO.,LTD

Bare-metal biliary stent

• Primary Device ID: 08809909414114
• NIH Device Record Key: c6f77ef8-e675-46b0-9e01-90e7987d6160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Niti-S Biliary Speed D Stent
• Version Model Number: BDM0810
• 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: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French
• Stent Diameter: 8 Millimeter
• Stent Length: 100 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 8.5 French

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	08809909414114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223626

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

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: 2023-06-09
• Device Publish Date: 2023-06-01

On-Brand Devices [Niti-S Biliary Speed D Stent]

• 08809909414053: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414206: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414190: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414183: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414176: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414169: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414152: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414145: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414138: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414121: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414114: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414107: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414091: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414084: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414077: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle
• 08809909414060: The Niti-S Biliary Speed D Stent consists of an implantable metallic stent and a disposable, fle