FDA UDI
In Commercial Distribution
🇺🇸 United States
HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)
DI: 08806367076595
·
Model: DNJF-20-090-230
·
M.I.Tech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)
- Primary DI
- 08806367076595
- Version / Model
- DNJF-20-090-230
- 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
- 2018-11-20
- Public Version
- 1
- Public Version Date
- 2018-12-21
- Public Version Status
- New
- Public Device Record Key
- 5ece2ff8-3da9-4cde-8955-1466770f3d08
Device Description
Un-covered self-expanding nitinol Duodenum 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 Unsafe
- 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 |
|---|---|---|---|---|
| MUM | Stent, Metallic, Expandable, Duodenal | General, Plastic Surgery | 878.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32640 | Bare-metal duodenal stent | A sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded 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 | 08806367076595 | GS1 |
Customer Contacts
- Phone
- +827043047405
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180180 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2300 | Millimeter | |
| Stent Length | 90 | Millimeter | |
| Stent Diameter | 20 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius