FDA UDI
In Commercial Distribution
🇺🇸 United States
Azur Pushable Helical
DI: 00810170017445
·
Model: 45-250820
·
MICROVENTION INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Azur Pushable Helical
- Primary DI
- 00810170017445
- Version / Model
- 45-250820
- Catalog Number
- 45-250820
- Company Name
- MICROVENTION INC.
- Labeler DUNS
- 003263105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-29
- Public Version
- 6
- Public Version Date
- 2022-03-28
- Public Version Status
- Update
- Public Device Record Key
- 46fbdd54-8467-4123-9158-e299a453e24c
Device Description
Azur
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 |
|---|---|---|---|---|
| KRD | Device, Vascular, for Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60941 | Non-neurovascular embolization coil | A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; 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 |
|---|---|---|---|---|---|---|
| Package | 10810170017442 | GS1 | Carton | 3 | In Commercial Distribution | |
| Primary | 00810170017445 | GS1 |
Customer Contacts
- Phone
- +1(714)247-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8 mm x 20 cm |