Niti-S Duodenal Comfort Stent

GUDID 08809909414329

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

TAEWOONGMEDICAL.CO.,LTD

Bare-metal duodenal stent

• Primary Device ID: 08809909414329
• NIH Device Record Key: 671fd2df-b667-416e-ad66-f60d6cb91f24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Niti-S Duodenal Comfort Stent
• Version Model Number: PDT2206N-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
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 French
• Stent Diameter: 22 Millimeter
• Stent Length: 60 Millimeter
• Catheter Working Length: 220 Centimeter
• Crossing Profile: 10 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	08809909414329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223067

FDA Product Code

• MUM: Stent, Metallic, Expandable, Duodenal

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 Duodenal Comfort Stent]

• 08809909414350: The Niti-S Duodenal Comfort Stent consists of an implantable metallic stent and a disposable, fl
• 08809909414343: The Niti-S Duodenal Comfort Stent consists of an implantable metallic stent and a disposable, fl
• 08809909414336: The Niti-S Duodenal Comfort Stent consists of an implantable metallic stent and a disposable, fl
• 08809909414329: The Niti-S Duodenal Comfort Stent consists of an implantable metallic stent and a disposable, fl