BONASTENT® Tracheal/Bronchial

GUDID 08806369468848

Sewoon Medical Co., Ltd.

Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent Polymer-metal tracheal/bronchial stent

• Primary Device ID: 08806369468848
• NIH Device Record Key: 3626c09f-2f35-4e3a-9a33-d6da3e825d14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BONASTENT® Tracheal/Bronchial
• Version Model Number: BTB-160309
• Company DUNS: 687784405
• Company Name: Sewoon Medical Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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 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	08806369468848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140472

FDA Product Code

• JCT: Prosthesis, Tracheal, Expandable

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: 2021-02-19
• Device Publish Date: 2017-03-03

On-Brand Devices [BONASTENT® Tracheal/Bronchial]

• 08806369469449: BTB-140209
• 08806369469425: BTB-200809
• 08806369469401: BTB-200709
• 08806369469388: BTB-200609
• 08806369469364: BTB-200509
• 08806369469340: BTB-200409
• 08806369469326: BTB-200309
• 08806369469302: BTB-200805
• 08806369469289: BTB-200705
• 08806369469265: BTB-200605
• 08806369469241: BTB-200505
• 08806369469227: BTB-200405
• 08806369469203: BTB-200305
• 08806369469180: BTB-180809
• 08806369469166: BTB-180709
• 08806369469142: BTB-180609
• 08806369469128: BTB-180509
• 08806369469104: BTB-180409
• 08806369469081: BTB-180309
• 08806369469067: BTB-180805
• 08806369469043: BTB-180705
• 08806369469029: BTB-180605
• 08806369469005: BTB-180505
• 08806369468985: BTB-180405
• 08806369468961: BTB-180305
• 08806369468947: BTB-160809
• 08806369468923: BTB-160709
• 08806369468909: BTB-160609
• 08806369468886: BTB-160509
• 08806369468862: BTB-160409
• 08806369468848: BTB-160309
• 08806369468824: BTB-160805
• 08806369468800: BTB-160705
• 08806369468787: BTB-160605
• 08806369468763: BTB-160505
• 08806369468749: BTB-160405
• 08806369468725: BTB-160305
• 08806369468701: BTB-140809
• 08806369468688: BTB-140709
• 08806369468664: BTB-140609
• 08806369468640: BTB-140509
• 08806369468626: BTB-140409
• 08806369468602: BTB-140309
• 08806369468589: BTB-140805
• 08806369468565: BTB-140705
• 08806369468541: BTB-140605
• 08806369468527: BTB-140505
• 08806369468503: BTB-140405
• 08806369468480: BTB-140305
• 08806369468466: BTB-120809