MasterSL Hip 9035.15.280

GUDID 08033390082983

Broach #8

LIMACORPORATE SPA

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach
Primary Device ID08033390082983
NIH Device Record Key5d4ae1ca-24a4-4af9-8312-ddbed96f34e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasterSL Hip
Version Model NumberBroach
Catalog Number9035.15.280
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390082983 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


[08033390082983]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2021-03-18
Device Publish Date2016-04-12

On-Brand Devices [MasterSL Hip]

08033390090735Lateralized Trial Neck
08033390090728Standard Trial Neck
08033390083034Broach #13
08033390083027Broach #12
08033390083010Broach #11
08033390083003Broach #10
08033390082990Broach #9
08033390082983Broach #8
08033390082976Broach #7
08033390082969Broach #6
08033390082952Broach #5
08033390082945Broach #4
08033390082938Broach #3
08033390082921Broach #2
08033390082914Broach #1
08033390197793Broach #13
08033390197786Broach #12
08033390197779Broach #11
08033390197762Broach #10
08033390197755Broach #9
08033390197748Broach #8
08033390197731Broach #7
08033390197724Broach #6
08033390197717Broach #5
08033390197700Broach #4
08033390197694Broach #3
08033390197687Broach #2
08033390197670Broach #1
08033390085304Woodpecker Straight Adapter
08033390084109MasterSL Hip - Osteotomy Guide
08033390083362MasterSL Hip - Calcar Reamer Plastic Protection
08033390083355MasterSL Hip - Calcar Reamer
08033390081658Reamer
08033390083386Broach Handle

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