FDA UDI
In Commercial Distribution
🇺🇸 United States
EDG v4
DI: 04540778178113
·
Model: 347-404U
·
KANEKA CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EDG v4
- Primary DI
- 04540778178113
- Version / Model
- 347-404U
- Catalog Number
- 347-404U
- Company Name
- KANEKA CORPORATION
- Labeler DUNS
- 690535406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-30
- Public Version
- 5
- Public Version Date
- 2023-09-11
- Public Version Status
- Update
- Public Device Record Key
- ade5b67a-b915-48e9-8a4f-040a8a62ec4b
Device Description
ELECTRO DETACH GENERATOR v4 (Model: “EDG v4”) is used to detach the platinum coil from the pusher of i-ED COIL manufactured by Kaneka Corporation.
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | 870.3300 | 2 |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04540778178113 | GS1 |
Customer Contacts
- Phone
- (800) 526-3522
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No Device Sizes |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal