BIOCERAM AZUL HEAD GMH04-400073

GUDID 04580810059604

AZUL HEAD 40 +3.5 "Size: φ40MM O.D. Offset: +3.5mm Taper: 12/14"

KYOCERA MEDICAL CORPORATION

Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: 04580810059604
• NIH Device Record Key: 2d2d17fd-8ecc-4aff-a73a-9e73007a528d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOCERAM AZUL HEAD
• Version Model Number: GMH04-400073
• Catalog Number: GMH04-400073
• Company DUNS: 691363290
• Company Name: KYOCERA MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com
• Phone: 909-557-2360
• Email: kmti.info@kyocera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547898308222 [Previous]
GS1	04580810059604 [Primary]

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-15
• Device Publish Date: 2025-12-05

On-Brand Devices [BIOCERAM AZUL HEAD]

• 04580810059482: AZUL HEAD 28 +3.5 "Size: φ28MM O.D. Offset: +3.5mm Taper: 12/14"
• 04580810059604: AZUL HEAD 40 +3.5 "Size: φ40MM O.D. Offset: +3.5mm Taper: 12/14"
• 04580810059574: AZUL HEAD 36 +7 "Size: φ36MM O.D. Offset: +7mm Taper: 12/14"
• 04580810059550: AZUL HEAD 36 +0 "Size: φ36MM O.D. Offset: +0mm Taper: 12/14"
• 04580810059536: AZUL HEAD 32 +7 "Size: φ32MM O.D. Offset: +7mm Taper: 12/14"
• 04580810059468: AZUL 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"
• 04580810059475: AZUL 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"