FDA UDI
In Commercial Distribution
🇺🇸 United States
AZUR Detachment Controller
DI: 00840273201991
·
Model: 45-4001-02
·
Microvention, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AZUR Detachment Controller
- Primary DI
- 00840273201991
- Version / Model
- 45-4001-02
- Catalog Number
- 45-4001
- Company Name
- Microvention, Inc.
- Labeler DUNS
- 003263105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-28
- Public Version
- 2
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- f17df65c-d8b5-4502-bc5f-17b4ea251cae
Device Description
AZUR Detachment Controller
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 Unsafe
- 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 |
|---|---|---|---|---|
| 60637 | Vascular implant detacher, electronic, single-use | A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840273201991 | GS1 |
Customer Contacts
- Phone
- +1(714) 247-8000
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- High: 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry. Keep away from sunlight.