FDA UDI
In Commercial Distribution
🇺🇸 United States
Esophageal TTS Stent
DI: 08809744973111
·
Model: EST2210B
·
TAEWOONGMEDICAL.CO.,LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Esophageal TTS Stent
- Primary DI
- 08809744973111
- Version / Model
- EST2210B
- Company Name
- TAEWOONGMEDICAL.CO.,LTD
- Labeler DUNS
- 689484322
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 3
- Public Version Date
- 2026-04-08
- Public Version Status
- Update
- Public Device Record Key
- fcf35a64-6a13-4575-9c8d-a88ea18ed728
Device Description
Partially Covered Esophageal Stent 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
- No
- 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 |
|---|---|---|---|---|
| ESW | Prosthesis, Esophageal | General, Plastic Surgery | 878.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61751 | Polymer-metal oesophageal stent | A non-bioabsorbable, expandable, tubular device intended to be implanted into the oesophagus to maintain luminal patency in strictures, prevent tumour in-growth, seal oesophageal fistulas, reduce acute bleeding from oesophageal varices, and/or to treat other lesions causing oesophageal leakage (e.g., anastomotic). It consists of a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. It is typically expanded in situ (e.g., 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 | 08809744973111 | GS1 |
Customer Contacts
- Phone
- 323-692-0028
- [email protected]
- Phone
- +82319960641
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211706 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Diameter | 22 | Millimeter | |
| Stent Length | 10 | Centimeter | |
| Catheter Working Length | 180 | Centimeter | |
| Device Size Text, specify | 15 mm bare at both ends of the Stent |