Acetabular Insert 2099-2861

GUDID 07613327031591

Acetabular Insert

Howmedica Osteonics Corp.

Polyethylene acetabulum prosthesis
Primary Device ID07613327031591
NIH Device Record Keybd712903-8896-4658-90f1-d0263f1514f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Insert
Version Model Number2099-2861
Catalog Number2099-2861
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 Diameter28 Millimeter
Outer Diameter61 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327031591 [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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07613327031478Acetabular Insert
07613327031461Acetabular Insert
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07613327031447Acetabular Insert
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