FDA UDI
In Commercial Distribution
🇺🇸 United States
WEB Aneurysm Embolization System
DI: 00856956005541
·
Model: W2-8-S
·
SEQUENT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WEB Aneurysm Embolization System
- Primary DI
- 00856956005541
- Version / Model
- W2-8-S
- Catalog Number
- FGA15080-001
- Company Name
- SEQUENT MEDICAL, INC.
- Labeler DUNS
- 796807340
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-01
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 49874b50-3d71-4eb7-bf9c-016fb423fccc
Device Description
WEB 27 SLS 8
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
- 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 |
|---|---|---|---|---|
| OPR | Intrasaccular Flow Disruption Device | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60940 | Neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856956005541 | GS1 |
Customer Contacts
- Phone
- 949.830.9600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170032 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8 x 6.6 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at a controlled room temperature in a dry place