MasterSL Hip 9035.15.430

GUDID 08033390197694

Broach #3

LIMACORPORATE SPA

Orthopaedic broach
Primary Device ID08033390197694
NIH Device Record Key3886617d-21c1-4d75-a103-fd03fe93a3d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasterSL Hip
Version Model Number9035.15.430
Catalog Number9035.15.430
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
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 Identifiers

Device Issuing AgencyDevice ID
GS108033390197694 [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

[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


[08033390197694]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-26
Device Publish Date2021-03-18

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.