Delta Dual Mobility System 5885.09.040

GUDID 08033390086332

Liner #M for Mobile Liner Dia. 40 mm

LIMACORPORATE SPA

Ceramic acetabular liner
Primary Device ID08033390086332
NIH Device Record Key3e6a60f5-f72e-44fd-a3d5-f1c4fd0087b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelta Dual Mobility System
Version Model Number5885.09.040
Catalog Number5885.09.040
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390086332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-03
Device Publish Date2019-06-25

On-Brand Devices [Delta Dual Mobility System]

08033390086332Liner #M for Mobile Liner Dia. 40 mm
08033390086325Mobile Liner Dia. 40 mm for Head Dia. 28 mm
08033390020060Liner #L for Mobile Liner Dia. 42 mm
08033390012447Mobile Liner Dia. 42 mm for Head Dia. 28 mm

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