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Bioceram Azul Head GMH04-400071

by Kyocera Medical Corporation

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

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 Number04580810059581 UDI-DI Date16 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bioceram Azul Head
Generic Name
Ceramic-on-polyethylene total hip prosthesis
Model / Reference
GMH04-400071
Description
"AZUL HEAD 40 -3.5 Size: φ40MM O.D. Offset: -3.5mm Taper: 12/14"
Primary DI / UDI-DI
04580810059581
FDA Product Code
LZO
GMDN Term
Ceramic-on-polyethylene total hip prosthesis
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution

Other devices from Kyocera Medical Corporation

See all devices from Kyocera Medical Corporation →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial 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
  • Lot / Batch Number: No
  • Manufacturing Date: No