BIOCERAM AZUL HEAD GMH04-400058

GUDID 04580810059482

Ceramic-on-polyethylene total hip prosthesis

Primary Device ID	04580810059482
NIH Device Record Key	e142a05b-0e2b-4a04-9f21-20c2742c3b0b
Commercial Distribution Status	In Commercial Distribution
Brand Name	BIOCERAM AZUL HEAD
Version Model Number	GMH04-400058
Catalog Number	GMH04-400058
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

Device Issuing Agency	Device ID
GS1	04547898308116 [Previous]
GS1	04580810059482 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true

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"