Acetabular Insert 2099-2874

GUDID 07613327031621

Acetabular Insert

Howmedica Osteonics Corp.

Polyethylene acetabulum prosthesis
Primary Device ID07613327031621
NIH Device Record Key1d3b4614-8bfe-4529-94ba-475638e5d993
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Insert
Version Model Number2099-2874
Catalog Number2099-2874
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

Outer Diameter74 Millimeter
Lumen/Inner Diameter28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327031621 [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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