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Grace Piston 412-525

by Grace Medical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844505014526 UDI-DI Date7 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2308-2026 FDA Class II initiated 3 Apr 2026

    Due to incorrect functional length on device labeling.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Grace Piston
Generic Name
Ossicular prosthesis, partial
Model / Reference
412-525
Primary DI / UDI-DI
00844505014526
510(k) Number
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

Related devices

Cleared under the same submission (K060518)

Show all (12)

Other devices from Grace Medical, Inc.

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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