FDA UDI
In Commercial Distribution
🇺🇸 United States
HANAROSTENT® Trachea/Bronchium(CCC)
DI: 08806367080004
·
Model: TCS-10-070-090
·
M.I.Tech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HANAROSTENT® Trachea/Bronchium(CCC)
- Primary DI
- 08806367080004
- Version / Model
- TCS-10-070-090
- Company Name
- M.I.Tech Co., Ltd.
- Labeler DUNS
- 688454359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-30
- Public Version
- 1
- Public Version Date
- 2021-05-10
- Public Version Status
- New
- Public Device Record Key
- 5bf06943-9180-4692-b3d3-2dc6c5485ccd
Device Description
Full Covered metallic tracheal stent
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 | 08806367080004 | GS1 |
Customer Contacts
- Phone
- +827043047474
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201342 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Diameter | 10 | Millimeter | |
| Stent Length | 70 | Millimeter | |
| Device Size Text, specify | 900 mm Delivery system |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius