FDA UDI
In Commercial Distribution
🇺🇸 United States
V-Grip Detachment Controller
DI: 00810170012112
·
Model: VG501
·
MICROVENTION INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- V-Grip Detachment Controller
- Primary DI
- 00810170012112
- Version / Model
- VG501
- Catalog Number
- VG501
- Company Name
- MICROVENTION INC.
- Labeler DUNS
- 003263105
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- 0c69f8fd-5066-4d7f-a7a8-ab9e1feecdd1
Device Description
Coil Accessories
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 |
|---|---|---|---|---|
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | Neurology | 882.5950 | 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 |
|---|---|---|---|---|---|---|
| Package | 10810170012119 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 00810170012112 | GS1 |
Customer Contacts
- Phone
- +1(714)247-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0 |