Acetabular Instrument Set 9058.85.220

GUDID 08033390066181

Liner Positioner MEDIUM-LARGE Dia.36 mm

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390066181
NIH Device Record Keyc0796f37-09f6-4b9e-88c0-5602ba3574cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Instrument Set
Version Model NumberLiner Positioner
Catalog Number9058.85.220
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 Identifiers

Device Issuing AgencyDevice ID
GS108033390066181 [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

[08033390066181]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-06-17

On-Brand Devices [Acetabular Instrument Set]

08033390066198Liner Positioner LARGE Dia.40 mm
08033390066181Liner Positioner MEDIUM-LARGE Dia.36 mm
08033390066174Liner Positioner SMALL Dia.32 mm
0803339006457645° Joint for Beater
08033390064569Joint for Ceramic Liner Posititioner
0803339006336445° Joint for Ceramic Liner Posititioner
08033390025744Beater-Positioner-Aligner
08033390137126Cannulated Handle M6 with Flange

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