Instrument Set 9095.10.543

GUDID 08033390057592

Trial Head LOW Taper=12/14 Dia=40 mm - L

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable
Primary Device ID08033390057592
NIH Device Record Key65ac5975-36a3-47f8-9f0c-9b82ba687967
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrument Set
Version Model NumberTrial Head
Catalog Number9095.10.543
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
GS108033390057592 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


[08033390057592]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-12-21
Device Publish Date2016-08-05

On-Brand Devices [Instrument Set]

08033390057608Trial Head LOW Taper=12/14 Dia=40 mm - XL
08033390057592Trial Head LOW Taper=12/14 Dia=40 mm - L
08033390057585Trial Head LOW Taper=12/14 Dia=40 mm - M
08033390057578Trial Head LOW Taper=12/14 Dia=40 mm - S
08033390022484Trial Head LOW Taper=12/14 Dia=36 mm - XL
08033390021685Trial Head LOW Taper=12/14 Dia=28 mm - L
08033390021678Trial Head LOW Taper=12/14 Dia=28 mm - M
08033390021661Trial Head LOW Taper=12/14 Dia=28 mm - S
08033390021470Trial Head LOW Taper=12/14 Dia=36 mm - L
08033390021463Trial Head LOW Taper=12/14 Dia=36 mm - S
08033390021395Trial Head LOW Taper=12/14 Dia=32 mm - L
08033390021388Trial Head LOW Taper=12/14 Dia=32 mm - S
08033390021142Trial Head LOW Taper=12/14 Dia=36 mm - M
08033390021135Trial Head LOW Taper=12/14 Dia=32 mm - M
08033390064972Offset Femoral Elevator
08033390064965Femoral Elevator
08033390064958Single Pronge Narrow Hohmann Retrac (25mm)
08033390064941Single Pronge Large Hohmann Retrac. (35mm)
08033390064934Cobra Style Hohmann Retractor
08033390064927Incision Ruler

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