SMR Resurfacing System 9013.27.200

GUDID 08033390038621

K. Wire Guide

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08033390038621
NIH Device Record Keye45661c6-7382-470a-b730-ffd5440ac786
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Resurfacing System
Version Model NumberK. Wire Guide
Catalog Number9013.27.200
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
GS108033390038621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


[08033390038621]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-03
Device Publish Date2016-04-05

On-Brand Devices [SMR Resurfacing System]

08033390038423Trial Stem Dia.13mm
08033390038416Trial Stem Dia.11mm
08033390038621K. Wire Guide

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