SMR 9CCA.13.012

GUDID 08033390111256

SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm

LIMACORPORATE SPA

Bone-resection orthopaedic reamer, reusable
Primary Device ID08033390111256
NIH Device Record Keyf5a814a7-2b53-4698-ac69-71b7d4f57720
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR
Version Model NumberHEMISPHERICAL HUMERAL REAMER
Catalog Number9CCA.13.012
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
GS108033390111256 [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

[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


[08033390111256]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-23
Device Publish Date2016-08-05

On-Brand Devices [SMR ]

08033390111263SMR : HEMISPHERICAL HUMERAL REAMER Ø54mm
08033390111256SMR : HEMISPHERICAL HUMERAL REAMER Ø50mm
08033390111249SMR : HEMISPHERICAL HUMERAL REAMER Ø46mm
08033390111232SMR : HEMISPHERICAL HUMERAL REAMER Ø42mm
08033390240055SMR - Modular head plate for press
08033390240048SMR - Modular head pusher for press

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