TEMA Elbow System 9CC0.95.092

GUDID 08033390151313

Flexible Reamer # 9

LIMACORPORATE SPA

Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible Medullary canal orthopaedic reamer, flexible
Primary Device ID08033390151313
NIH Device Record Keyc2b32046-5bea-4beb-be51-cc32beef8540
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMA Elbow System
Version Model Number9CC0.95.092
Catalog Number9CC0.95.092
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390151313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDBProsthesis, Elbow, Semi-Constrained, Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


[08033390151313]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-06
Device Publish Date2021-11-27

On-Brand Devices [TEMA Elbow System ]

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08033390151313Flexible Reamer # 9
08033390151306Flexible Reamer # 8
08033390151290Flexible Reamer # 7
08033390151283Flexible Reamer # 6
08033390151276Flexible Reamer # 5
08033390151269Flexible Reamer # 4
08033390151252Flexible Reamer # 3

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