i-ED COIL 373-040815

by Kaneka Corp.

i-ED COIL 373-040815 is a Class II device made by Kaneka Corp., listed in FDA GUDID since 30 Jun 2020 (UDI-DI 04540778177635), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04540778177635 UDI-DI	Date30 Jun 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 04540778177635

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: i-ED COIL
Generic name: Non-neurovascular embolization coil
Model / Ref / Catalog: 373-040815

Primary DI / UDI-DI: 04540778177635
FDA product code: HCG, KRD
GMDN term: Non-neurovascular embolization coil

Device class: Class II
Regulation number: 882.5950, 870.3300
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Other devices from Kaneka Corp.

Ed Coil

Class III
i-ED COIL 392-0615

Class II
i-ED COIL 392-0720

Class II
i-ED COIL 393-020320

Class II

See all devices from Kaneka Corp. →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date

Other properties (9, all answered No)