Niti-S Biliary Slim M Stent

GUDID 08809744975351

Bare Metal Biliary Stent System

TAEWOONGMEDICAL.CO.,LTD

Bare-metal biliary stent

• Primary Device ID: 08809744975351
• NIH Device Record Key: d407f3a4-57e0-430b-add3-99571e1d79cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Niti-S Biliary Slim M Stent
• Version Model Number: BN0807-6
• 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

Device Dimensions

• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 French
• Stent Diameter: 8 Millimeter
• Stent Length: 70 Millimeter
• Catheter Working Length: 180 Centimeter
• Crossing Profile: 6 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809744975351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221071

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: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [Niti-S Biliary Slim M Stent]

• 08809744975399: Bare Metal Biliary Stent System
• 08809744975382: Bare Metal Biliary Stent System
• 08809744975375: Bare Metal Biliary Stent System
• 08809744975368: Bare Metal Biliary Stent System
• 08809744975351: Bare Metal Biliary Stent System
• 08809744975344: Bare Metal Biliary Stent System
• 08809744975337: Bare Metal Biliary Stent System
• 08809744975320: Bare Metal Biliary Stent System
• 08809744975313: Bare Metal Biliary Stent System
• 08809744975306: Bare Metal Biliary Stent System
• 08809744975290: Bare Metal Biliary Stent System
• 08809744975283: Bare Metal Biliary Stent System
• 08809744975276: Bare Metal Biliary Stent System
• 08809744975269: Bare Metal Biliary Stent System
• 08809744975252: Bare Metal Biliary Stent System
• 08809744975245: Bare Metal Biliary Stent System