SMR 9013.22.202

GUDID 08033390240055

SMR - Modular head plate for press

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08033390240055
NIH Device Record Key0007939b-87b9-4200-908f-3303e21538e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMR
Version Model Number9013.22.202
Catalog Number9013.22.202
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
GS108033390240055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


[08033390240055]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-03
Device Publish Date2023-10-26

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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