Acetabular Insert 2099-2656

GUDID 07613327031546

Acetabular Insert

Howmedica Osteonics Corp.

Polyethylene acetabulum prosthesis
Primary Device ID07613327031546
NIH Device Record Key41f1ddbb-be56-46f8-928e-c003a37a7d6e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Insert
Version Model Number2099-2656
Catalog Number2099-2656
Company DUNS058311945
Company NameHowmedica Osteonics Corp.
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 Usetrue
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

Lumen/Inner Diameter26 Millimeter
Outer Diameter56 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327031546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

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07613327031553Acetabular Insert
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07613327031539Acetabular Insert
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07613327031508Acetabular Insert
07613327031492Acetabular Insert
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07613327031478Acetabular Insert
07613327031461Acetabular Insert
07613327031454Acetabular Insert
07613327031447Acetabular Insert
07613327031430Acetabular Insert

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