BONASTENT® Esophageal

GUDID 08806369458603

Sewoon Medical Co., Ltd.

Polymer-metal oesophageal stent, sterile

• Primary Device ID: 08806369458603
• NIH Device Record Key: e687d415-5ea1-4f25-b62c-5f7c360cbc2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONASTENT® Esophageal
• Version Model Number: BER-1816
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806369458603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092144

FDA Product Code

• ESW: Prosthesis, Esophageal

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® Esophageal]

• 08806369459105: BE-1816
• 08806369459082: BE-1814
• 08806369459068: BE-1812
• 08806369459044: BE-1810
• 08806369459020: BE-1808
• 08806369459006: BE-1806
• 08806369458603: BER-1816
• 08806369458580: BER-1814
• 08806369458566: BER-1812
• 08806369458542: BER-1810
• 08806369458528: BER-1808
• 08806369458504: BER-1806