H-Max Hip 9042.05.080

GUDID 08033390062824

Broach #8

LIMACORPORATE SPA

Orthopaedic broach
Primary Device ID08033390062824
NIH Device Record Key228db51e-0d9c-4026-a024-d675ec3cd5bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameH-Max Hip
Version Model NumberBroach
Catalog Number9042.05.080
Company DUNS432066322
Company NameLIMACORPORATE SPA
Device Count1
DM Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
GS108033390062824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390062824]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-05
Device Publish Date2016-05-12

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08033390001410 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.50mm
08033390001427 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.52mm
08033390001434 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.54mm
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