FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuroform Atlas
DI: 07613252656050
·
Model: M003STAS40150
·
Stryker Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuroform Atlas
- Primary DI
- 07613252656050
- Version / Model
- M003STAS40150
- Catalog Number
- STAS4015
- Company Name
- Stryker Corporation
- Labeler DUNS
- 042405446
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-12
- Public Version
- 5
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 4e4c2037-fa31-49cf-b03c-bfaa1cd296fb
Device Description
WITH TIP 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 | 07613252656050 | GS1 |
Customer Contacts
- Phone
- +1(855)916-3876
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H020002 | 046 |
| H020002 | 051 |
| H020002 | 052 |
| H020002 | 053 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15.0 | Millimeter | |
| Outer Diameter | 4.0 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dry, dark place.