FDA UDI
In Commercial Distribution
🇺🇸 United States
BONASTENT® Tracheal/Bronchial
DI: 08806369469005
·
Model: BTB-180505
·
Sewoon Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BONASTENT® Tracheal/Bronchial
- Primary DI
- 08806369469005
- Version / Model
- BTB-180505
- Company Name
- Sewoon Medical Co., Ltd.
- Labeler DUNS
- 687784405
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-03
- Public Version
- 5
- Public Version Date
- 2021-10-25
- Public Version Status
- Update
- Public Device Record Key
- 91ffe898-cb42-45a7-9499-805c335eaca4
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | 878.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43630 | Polymer-metal tracheal/bronchial stent | A non-bioabsorbable tubular device intended to be implanted into an obstructed or stenosed trachea and/or bronchus/bronchiole to maintain luminal patency. It is made of both metallic and synthetic polymer materials (e.g., metal mesh with a polymeric cover/lining, or polymeric tubular body with metallic support structures), and may have a straight or branched configuration. It may be expandable in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806369469005 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140472 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 50mm Stent Length | ||
| Device Size Text, specify | 18mm Stent Diameter |