Bipolar Head 9050.10.580

GUDID 08033390032469

Trial Head Dia.51mm

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable
Primary Device ID08033390032469
NIH Device Record Keyd07467ab-b13e-4c90-98b9-d2ec5260de27
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar Head
Version Model NumberTrial Head
Catalog Number9050.10.580
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390032469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


[08033390032469]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-12-21
Device Publish Date2016-06-17

On-Brand Devices [Bipolar Head]

08033390112314Trial Head Inserter
08033390032506Trial Head Dia.54mm
08033390032490Trial Head Dia.53mm
08033390032476Trial Head Dia.52mm
08033390032469Trial Head Dia.51mm
08033390032452Trial Head Dia.50mm
08033390032445Trial Head Dia.49mm
08033390032438Trial Head Dia.48mm
08033390032414Trial Head Dia.47mm
08033390032407Trial Head Dia.46mm
08033390032391Trial Head Dia.45mm

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