SMR Resurfacing System 9013.17.010

GUDID 08033390038416

Trial Stem Dia.11mm

LIMACORPORATE SPA

Humeral stem prosthesis trial, reusable
Primary Device ID08033390038416
NIH Device Record Key8b3426d6-e4cb-473e-b0a7-2479ddf39b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR Resurfacing System
Version Model NumberTrial Stem
Catalog Number9013.17.010
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
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Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390038416 [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

[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


[08033390038416]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-07-04
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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