SMR STEMLESS 9013.55.015

GUDID 08033390108058

SMR STEMLESS Shoulder - Cutting Template

LIMACORPORATE SPA

Orthopaedic reamer guide
Primary Device ID08033390108058
NIH Device Record Key624bbbe2-d6df-44ed-b936-eff57750eb88
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR STEMLESS
Version Model Number9013.55.015
Catalog Number9013.55.015
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 Identifiers

Device Issuing AgencyDevice ID
GS108033390108058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

[08033390108058]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

On-Brand Devices [SMR STEMLESS]

08033390108065SMR STEMLESS - Reamer Shaft
08033390192132SMR STEMLESS Shoulder - K-Wire Centering Sleeve Extended
08033390109925SMR STEMLESS Shoulder - #X-LARGE Introducer
08033390109918SMR STEMLESS Shoulder - #LARGE Introducer
08033390109901SMR STEMLESS Shoulder - #MEDIUM Introducer
08033390109895SMR STEMLESS - Introducer SMALL
08033390109888SMR STEMLESS Shoulder - #X-SMALL Introducer
08033390109857SMR STEMLESS Shoulder - #X-LARGE Sizer
08033390109840SMR STEMLESS - Sizer Large
08033390109833SMR STEMLESS - Sizer Medium
08033390109826SMR STEMLESS - Sizer Small
08033390109819SMR STEMLESS Shoulder - #X-SMALL Sizer
08033390108294SMR STEMLESS Shoulder - #X-LARGE Stemless Core Removal Reamer
08033390108287SMR STEMLESS - #X-SMALL Stemless Core Removal Reamer
08033390108270SMR STEMLESS Shoulder - #X-LARGE Compactor
08033390108263SMR STEMLESS - Compactor Large
08033390108256SMR STEMLESS - Compactor Medium
08033390108249SMR STEMLESS - Compactor Small
08033390108232SMR STEMLESS Shoulder - #X-SMALL Compactor
08033390108225SMR STEMLESS Shoulder - #X-LARGE Short Compactor
08033390108218SMR STEMLESS - Compactor Large Short
08033390108201SMR STEMLESS - Compactor Medium Short
08033390108195SMR STEMLESS - Compactor Small Short
08033390108188SMR STEMLESS Shoulder - #X-SMALL Short Compactor
08033390108164SMR STEMLESS Shoulder - #X-LARGE Reamer
08033390108157SMR STEMLESS - Reamer Large
08033390108140SMR STEMLESS - Reamer Medium
08033390108133SMR STEMLESS - Reamer Small
08033390108126SMR STEMLESS Shoulder - #X-SMALL Reamer
08033390108119SMR STEMLESS Shoulder - #X-LARGE Short Reamer
08033390108102SMR STEMLESS - Reamer Large Short
08033390108096SMR STEMLESS - Reamer Medium Short
08033390108089SMR STEMLESS - Reamer Small Short
08033390108072SMR STEMLESS Shoulder - #X-SMALL Short Reamer
08033390108058SMR STEMLESS Shoulder - Cutting Template
08033390108041SMR STEMLESS Shoulder - Connector for Trial Adaptors
08033390107877SMR STEMLESS - STEMLESS CORE # X-LARGE
08033390107860SMR STEMLESS - STEMLESS CORE # LARGE
08033390107853SMR STEMLESS - STEMLESS CORE # MEDIUM
08033390107846SMR STEMLESS - STEMLESS CORE # SMALL
08033390107839SMR STEMLESS - STEMLESS CORE # X-SMALL
08033390107822SMR STEMLESS - STEMLESS CORE # X-LARGE SHORT
08033390107815SMR STEMLESS - STEMLESS CORE # LARGE SHORT
08033390107808SMR STEMLESS - STEMLESS CORE # MEDIUM SHORT
08033390107792SMR STEMLESS - STEMLESS CORE # SMALL SHORT
08033390107785SMR STEMLESS - STEMLESS CORE # X-SMALL SHORT
08033390107778SMR STEMLESS - 4MM ECCENTRICAL ADAPTOR WITH SCREW
08033390107730SSMR STEMLESS - 2MM ECCENTRICAL ADAPTOR WITH SCREW
08033390107723SMR STEMLESS - NEUTRAL ADAPTOR WITH SCREW
08033390100663SMR STEMLESS - Core Removal Reamer Large
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