FDA.reportPublic FDA data

EDG v4

Primary DI
04540778178113
Brand
EDG v4
Company
KANEKA CORPORATION
Model
347-404U
Catalog number
347-404U
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.
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, For Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192068000i-ED COILKaneka Pharma America, LLC2020-04-25HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04540778178113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540778178113045407781781134540778178113

GMDN Terms#

Term, Definition table
TermDefinition
Vascular implant detacher, single-use, sterileA sterile, noninvasive, hand-held, battery-powered unit intended to deliver a low-level electric current to break the connection between a vascular (neurovascular or peripheral) implantable device, 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 desired electrically unstable detachment point. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 526-3522xx@xx.xx

Regulatory Flags#

DUNS number
690535406
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14993478010042LIXELLES-35N/A2024-10-25
14993478010059LIXELLES-15N/A2024-10-25
14993478010066LIXELLES-25N/A2024-10-25
14993478010110LIPOSORBERLA-15N/A2014-09-26
04540778177086i-ED COIL392-0615392-06152025-12-10
04540778177116i-ED COIL392-0720392-07202025-12-10
04540778193710i-ED COIL393-020320393-0203202025-12-10
04540778193727i-ED COIL393-020330393-0203302025-12-10
04540778171398LACRIFLOW CLLF-CL090A2017-06-01
04540778171381LACRIFLOW CLLF-CL105A2017-06-01
04540778177031i-ED COIL392-0408392-04082025-06-26
14993478020225Lixelle S-25N/A2015-05-01
14993478020232Lixelle S-35N/A2015-05-01
14993478020218Lixelle S-15N/A2015-05-01
04540778177291i-ED COIL393-030510393-0305102024-10-25
04540778190412i-ED COIL390-0212390-02122024-10-25
04540778190429i-ED COIL393-030530393-0305302024-10-25
24993478010049LIXELLES-35N/A2024-10-25
04993478010052LIXELLES-15N/A2024-10-25
04993478010069LIXELLES-25N/A2024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488734Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00847536032828AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033085AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.HCG2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.KRD2019-06-29