DELTA Cup Instrument Set 9055.50.025

GUDID 08033390025324

Trial Liner #LARGE for Head dia=32mm

LIMACORPORATE SPA

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Primary Device ID	08033390025324
NIH Device Record Key	f5c77260-3110-4c3c-b071-44696c003e59
Commercial Distribution Status	In Commercial Distribution
Brand Name	DELTA Cup Instrument Set
Version Model Number	Trial Liner
Catalog Number	9055.50.025
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	08033390025324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112898

FDA Product Code

LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented