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Na 3322-020

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10603295168621 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic cement, non-antimicrobial
Model / Ref / Catalog
3322-020, 3322020
Primary DI / UDI-DI
10603295168621
PMA Number
510(k) Number
FDA Product Code
LOD
GMDN Term
Orthopaedic cement, non-antimicrobial
Device Class
Class II
Regulation Number
888.3027
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Category: Orthopaedic cement, non-antimicrobial

Cleared under the same submission (K053003)

Cleared under the same submission (P960001)

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

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