Guide Screw for Trial Glenosphere 9CCA.13.015

GUDID 08033390113793

Guide Screw for Trial Glenosphere Dia.36 S-R - SMR Shoulder

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08033390113793
NIH Device Record Key20d3d5c8-12bf-4335-8ac9-967fec8cedaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Screw for Trial Glenosphere
Version Model NumberGuide Screw
Catalog Number9CCA.13.015
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390113793 [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

[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


[08033390113793]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-03
Device Publish Date2016-08-05

On-Brand Devices [Guide Screw for Trial Glenosphere]

08033390113793Guide Screw for Trial Glenosphere Dia.36 S-R - SMR Shoulder
08033390113786Guide Screw for Trial Glenosphere Dia.36 - SMR Shoulder

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