Bipolar Head 9050.10.585

GUDID 08033390032476

Trial Head Dia.52mm

LIMACORPORATE SPA

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Primary Device ID	08033390032476
NIH Device Record Key	5c2cf2a8-e6ca-4068-8a85-98b6a232ca6d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bipolar Head
Version Model Number	Trial Head
Catalog Number	9050.10.585
Company DUNS	432066322
Company Name	LIMACORPORATE SPA
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390032476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112158

FDA Product Code

JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented