FDA UDI
In Commercial Distribution
🇺🇸 United States
WALLSTENT® Endoprosthesis
DI: 08714729204107
·
Model: H965404310
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WALLSTENT® Endoprosthesis
- Primary DI
- 08714729204107
- Version / Model
- H965404310
- Catalog Number
- H965404310
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- 6fb19130-30eb-4725-bc4c-ca5539958335
Device Description
Self-Expanding 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 43589 | Bare-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 may be a straight or branched mesh structure, or continuous tube, and is made of metal [e.g., high-grade stainless steel, nickel-titanium alloy (Nitinol)]. It is typically expandable in situ (e.g., with a balloon catheter or is self-expandable); disposable devices intended to assist implantation may be included with the stent. | Yes | Active |
| 35458 | Trachea prosthesis | An implantable artificial substitute for the natural trachea used in airway reconstructive surgery. It is typically a semi-rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal trachea prosthesis may be uncovered or covered with a polymeric material. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729204107 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20 mm Stent Diameter | ||
| Device Size Text, specify | 75 cm Effective Length | ||
| Device Size Text, specify | 55 mm Stent Length |