FDA UDI
In Commercial Distribution
🇺🇸 United States
VENOUS WALLSTENT™
DI: 08714729979630
·
Model: H74912044205570
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VENOUS WALLSTENT™
- Primary DI
- 08714729979630
- Version / Model
- H74912044205570
- Catalog Number
- H74912044205570
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-30
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- f6eddd24-ae58-4459-93e4-c672306b1be8
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
- Yes
- 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 |
|---|---|---|---|---|
| QAN | Stent, iliac vein | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63844 | Bare-metal tracheal/bronchial/vascular stent | A non-bioabsorbable, tubular device intended to be implanted to indefinitely maintain patency/improve luminal diameter of a blood vessel (peripheral artery and/or vein) and, alternatively, the tracheobronchial tree; it may in addition be intended to be used in the biliary tract. It is not intended for implantation in a coronary or cerebral artery and not intended for shunting. It is a tubular bare-metal mesh implanted with a balloon catheter or delivery device (balloon and/or self-expanding). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729979630 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980033 | 050 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Stent Length | 55 | Millimeter | |
| Catheter Length | 75 | Centimeter | |
| Stent Diameter | 20 | Millimeter |