FDA UDI
In Commercial Distribution
🇺🇸 United States
LVIS Junior
DI: 00811425029923
·
Model: 172537-LVISJ
·
MICROVENTION INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LVIS Junior
- Primary DI
- 00811425029923
- Version / Model
- 172537-LVISJ
- Catalog Number
- 172537-LVISJ
- Company Name
- MICROVENTION INC.
- Labeler DUNS
- 003263105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-16
- Public Version
- 6
- Public Version Date
- 2021-11-29
- Public Version Status
- Update
- Public Device Record Key
- 0836dfaa-52af-45ef-abd2-0a75f9c172fb
Device Description
Low-Profile Visualized Intraluminal Support
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
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 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 | 00811425029923 | GS1 |
Customer Contacts
- Phone
- +1(714)247-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H130005 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.5 mm x 33 mm |