9095.11.754

GUDID 08033390196123

AO Torque Wrench 2.5Nm

LIMACORPORATE SPA

Surgical instrument handle, torque-limiting
Primary Device ID08033390196123
NIH Device Record Keyac86671f-6e4f-4e1d-b3c9-a3981b00c654
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9095.11.754
Catalog Number9095.11.754
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 Datetrue
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
GS108033390196123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRWDynamometer, Nonpowered
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


[08033390196123]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-16
Device Publish Date2022-09-08

Devices Manufactured by LIMACORPORATE SPA

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08033390001380 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.44mm
08033390001397 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.46mm
08033390001403 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.48mm
08033390001410 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.50mm
08033390001427 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.52mm
08033390001434 - SMR Shoulder2025-03-06 Humeral heads (CoCrMo) dia.54mm
08033390001557 - SMR Shoulder2025-03-06 CTA humeral heads (CoCrMo) dia.42mm

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