DELTA 9055.54.766

GUDID 08033390157490

Delta Trial Cups PRO - Cup Dia. 76 mm (Liner #2 EXTRA-LARGE)

LIMACORPORATE SPA

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Primary Device ID	08033390157490
NIH Device Record Key	1b5de168-885d-4801-aa13-56a67b5cd5eb
Commercial Distribution Status	In Commercial Distribution
Brand Name	DELTA
Version Model Number	9055.54.766
Catalog Number	9055.54.766
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	08033390157490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K191622

FDA Product Code

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