BIOCERAM AZUL HEAD

GUDID 04580810059468

AZUL HEAD 28 -3.5 Size: Ø28MM O.D. Offset: -3.5mm Taper: 12/14

KYOCERA MEDICAL CORPORATION

Ceramic-on-polyethylene total hip prosthesis
Primary Device ID04580810059468
NIH Device Record Key594d94b2-7d24-459a-9a7b-72344c9314b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOCERAM AZUL HEAD
Version Model NumberGMH04-400056
Company DUNS691363290
Company NameKYOCERA MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com
Phone909-557-2360
Emailkmti.info@kyocera.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104547898308093 [Previous]
GS104580810059468 [Primary]

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-19
Device Publish Date2026-02-11

On-Brand Devices [BIOCERAM AZUL HEAD]

04580810059482AZUL HEAD 28 +3.5 "Size: φ28MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059604AZUL HEAD 40 +3.5 "Size: φ40MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059574AZUL HEAD 36 +7 "Size: φ36MM O.D. Offset: +7mm Taper: 12/14"
04580810059550AZUL HEAD 36 +0 "Size: φ36MM O.D. Offset: +0mm Taper: 12/14"
04580810059536AZUL HEAD 32 +7 "Size: φ32MM O.D. Offset: +7mm Taper: 12/14"
04580810059468AZUL HEAD 28 -3.5 Size: Ø28MM O.D. Offset: -3.5mm Taper: 12/14
04580810059659"AZUL HEAD 44 +7 Size: φ44MM O.D. Offset: +7mm Taper: 12/14"
04580810059642"AZUL HEAD 44 +3.5 Size: φ44MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059635"AZUL HEAD 44 +0 Size: φ44MM O.D. Offset: +0mm Taper: 12/14"
04580810059628"AZUL HEAD 44 -3.5 Size: φ44MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059611"AZUL HEAD 40 +7 Size: φ40MM O.D. Offset: +7mm Taper: 12/14"
04580810059598"AZUL HEAD 40 +0 Size: φ40MM O.D. Offset: +0mm Taper: 12/14"
04580810059581"AZUL HEAD 40 -3.5 Size: φ40MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059567"AZUL HEAD 36 +3.5 Size: φ36MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059543"AZUL HEAD 36 -3.5 Size: φ36MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059529"AZUL HEAD 32 +3.5 Size: φ32MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059512"AZUL HEAD 32 +0 Size: φ32MM O.D. Offset: +0mm Taper: 12/14"
04580810059505"AZUL HEAD 32 -3.5 Size: φ32MM O.D. Offset: -3.5mm Taper: 12/14"
04580810059475AZUL HEAD 28 +0 Size: φ28MM O.D. Offset: +0mm Taper: 12/14"
04580810059499"AZUL HEAD 28 +7 Size: φ28MM O.D. Offset: +7mm Taper: 12/14"
04580810059451"AZUL HEAD 26 +3.5 Size: φ26MM O.D. Offset: +3.5mm Taper: 12/14"
04580810059444"AZUL HEAD 26 +0 Size: φ26MM O.D. Offset: +0mm Taper: 12/14"
04580810059437"AZUL HEAD 22 +3 Size: φ22MM O.D. Offset: +3mm Taper: 12/14"
04580810059420"AZUL HEAD 22 +0 Size: φ22MM O.D. Offset: +0mm Taper: 12/14"
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