BONASTENT® Biliary

GUDID 08806369461443

Sewoon Medical Co., Ltd.

Bare-metal biliary stent

• Primary Device ID: 08806369461443
• NIH Device Record Key: 126c9536-9f66-406a-bec4-87424eae7286
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONASTENT® Biliary
• Version Model Number: BB-100618
• Company DUNS: 687784405
• Company Name: Sewoon Medical 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: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08806369461443 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140760

FDA Product Code

• FGE: Catheter, Biliary, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-25
• Device Publish Date: 2017-03-03

On-Brand Devices [BONASTENT® Biliary]

• 08806369461528: BB-101018
• 08806369461504: BB-100918
• 08806369461481: BB-100818
• 08806369461467: BB-100718
• 08806369461443: BB-100618
• 08806369461429: BB-100518
• 08806369461245: BB-081018
• 08806369461221: BB-080918
• 08806369461207: BB-080818
• 08806369461184: BB-080718
• 08806369461160: BB-080618
• 08806369461146: BB-080518