FDA UDI
In Commercial Distribution
🇺🇸 United States
HANAROSTENT® FAST^TM Biliary (NNN)
DI: 08806367073334
·
Model: SHS-08-060-S180
·
M.I.Tech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HANAROSTENT® FAST^TM Biliary (NNN)
- Primary DI
- 08806367073334
- Version / Model
- SHS-08-060-S180
- 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
- 2019-03-18
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- b9783340-9378-413e-971b-6e155c9ad87a
Device Description
Un-covered self-expanding nitinol biliary stent with Short guidewire system
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 |
|---|---|---|---|---|
| FGE | Catheter, Biliary, Diagnostic | Gastroenterology, Urology | 876.5010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43691 | Bare-metal biliary stent | A non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. 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 | 08806367073334 | GS1 |
Customer Contacts
- Phone
- +827043047405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K183396 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Diameter | 08 | Millimeter | |
| Stent Length | 60 | Millimeter | |
| Device Size Text, specify | 1800mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius