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EDG v4

FDA UDI

Class II (US FDA UDI)

by Kaneka Corp.

Identity

Trade Name
EDG v4 FDA UDI
Generic Name
Vascular implant detacher, electronic, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
347-404U FDA UDI
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. FDA UDI

Identifiers

Catalog Number
347-404U FDA UDI
Primary DI / UDI-DI
04540778178113 FDA UDI
FDA Product Code
KRD FDA UDI
HCG FDA UDI
GMDN Term
Vascular implant detacher, electronic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
882.5950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Vascular implant detacher, electronic, single-use

EDG v4 by Kaneka Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular implant detacher, electronic, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kaneka Corp.

Sources (1)

  • FDA UDI ade5b67a-b915-48e9-8a4f-040a8a62ec4b 37 fields · synced May 30, 2026