BONASTENT® Tracheal/Bronchial
GUDID 08806369422819
Sewoon Medical Co., Ltd.
Polymer-metal tracheal/bronchial stent| Primary Device ID | 08806369422819 |
| NIH Device Record Key | 2fcbb82e-74c9-4e61-9fd0-f2b6dfab2e10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BONASTENT® Tracheal/Bronchial |
| Version Model Number | BTB-071012 |
| 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 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806369422819 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-10-22 |
On-Brand Devices [BONASTENT® Tracheal/Bronchial]
Trademark Results [BONASTENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONASTENT 77603874 3791959 Live/Registered |
SEWOON Medical Co., Ltd. 2008-10-30 |
BONASTENT 77603874 3791959 Live/Registered |
Standard Sci-Tech Inc. 2008-10-30 |
 BONASTENT 77536886 not registered Dead/Abandoned |
EndoChoice, Inc. 2008-08-01 |
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