Eclipse De La Cruz Piston 469-400

by Grace Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00844505005937 UDI-DI	Date18 Feb 2016Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Eclipse De La Cruz Piston
Generic Name: Ossicular prosthesis, partial
Model / Reference: 469-400

Primary DI / UDI-DI: 00844505005937
510(k) Number: K063374
FDA Product Code: ETB
GMDN Term: Ossicular prosthesis, partial

Device Class: Class II
Regulation Number: 874.3450
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Conditional

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Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (8)

Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No