00-8005-046-00

GUDID 00889024144231

Zimmer, Inc.

Metallic acetabulum prosthesis
Primary Device ID00889024144231
NIH Device Record Key0b4ea4d2-52dd-489a-9ee2-cc617351b9ff
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8005-46
Catalog Number00-8005-046-00
Company DUNS056038268
Company NameZimmer, Inc.
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)348-2759
Emailzimmer.consumerrelations@zimmerbiomet.com

Device Dimensions

Outer Diameter50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024144231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-14
Device Publish Date2015-09-17

Devices Manufactured by Zimmer, Inc.

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00889024646469 - Persona® The Personalized Knee®2024-05-28
00889024646476 - Persona® The Personalized Knee®2024-05-28
00889024646483 - Persona® The Personalized Knee®2024-05-28
00889024646506 - Persona® The Personalized Knee®2024-05-28
00889024646513 - Persona® The Personalized Knee®2024-05-28

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