FDA UDI
In Commercial Distribution
🇺🇸 United States
Wingspan
DI: 04546540722829
·
Model: M003WS0350090
·
Stryker Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wingspan
- Primary DI
- 04546540722829
- Version / Model
- M003WS0350090
- Catalog Number
- M003WS0350090
- Company Name
- Stryker Corporation
- Labeler DUNS
- 042405446
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-29
- Public Version
- 7
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 1be7bd37-49d8-4432-9275-5b058144e258
Device Description
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
- 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 |
|---|---|---|---|---|
| NJE | intracranial neurovascular stent | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46352 | Bare-metal intracranial vascular stent | A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). 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 | 04546540722829 | GS1 |
Customer Contacts
- Phone
- +1(855)916-3876
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H050001 | 001 |
| H050001 | 002 |
| H050001 | 003 |
| H050001 | 005 |
| H050001 | 006 |
| H050001 | 007 |
| H050001 | 013 |
| H050001 | 016 |
| H050001 | 017 |
| H050001 | 021 |
| H050001 | 023 |
| H050001 | 025 |
| H050001 | 028 |
| H050001 | 031 |
| H050001 | 032 |
| H050001 | 036 |
| H050001 | 040 |
| H050001 | 042 |
| H050001 | 049 |
| H050001 | 052 |
| H050001 | 055 |
| H050001 | 056 |
| H050001 | 057 |
| H050001 | 058 |
| H050001 | 059 |
| H050001 | 061 |
| H050001 | 064 |
| H050001 | 067 |
| H050001 | 070 |
| H050001 | 072 |
| H050001 | 086 |
| H050001 | 087 |
| H050001 | 088 |
| H050001 | 089 |
| H050001 | 090 |
| H050001 | 091 |
| H050001 | 092 |
| H050001 | 093 |
| H050001 | 094 |
| H050001 | 095 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9.0 | Millimeter | |
| Outer Diameter | 3.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, dark place.