SPH Cup 9057.20.524

GUDID 08033390021876

Trial Cup Dia=46mm - Acetabular Cup

LIMACORPORATE SPA

Acetabulum prosthesis trial, prefabricated, reusable
Primary Device ID08033390021876
NIH Device Record Key7e5a0470-ad49-4fc1-ac0f-cc70aabd8da3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPH Cup
Version Model NumberTrial Cup
Catalog Number9057.20.524
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390021876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


[08033390021876]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-12-21
Device Publish Date2016-07-27

On-Brand Devices [SPH Cup]

08033390021975Trial Cup Dia=66mm - Acetabular Cup
08033390021968Trial Cup Dia=64mm - Acetabular Cup
08033390021951Trial Cup Dia=62mm - Acetabular Cup
08033390021944Trial Cup Dia=60mm - Acetabular Cup
08033390021937Trial Cup Dia=58mm - Acetabular Cup
08033390021920Trial Cup Dia=56mm - Acetabular Cup
08033390021913Trial Cup Dia=54mm - Acetabular Cup
08033390021906Trial Cup Dia=52mm - Acetabular Cup
08033390021890Trial Cup Dia=50mm - Acetabular Cup
08033390021883Trial Cup Dia=48mm - Acetabular Cup
08033390021876Trial Cup Dia=46mm - Acetabular Cup
08033390021869Trial Cup Dia=44mm - Acetabular Cup

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