APR®

GUDID 00889024166905

Zimmer, Inc.

Non-constrained polyethylene acetabular liner
Primary Device ID00889024166905
NIH Device Record Keyd570f4e3-0609-42cf-9c92-e06852ce448c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAPR®
Version Model Number4338-28-067
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@zimmer.com

Device Dimensions

Lumen/Inner Diameter28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024166905 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-10-23

On-Brand Devices [APR®]

008890241826919400-99-211
008890241826849400-99-210
008890241826779400-99-201
008890241826609400-99-200
008890241826399400-00-100
008890241826229400-00-030
008890241779949326-00-103
008890241779879326-00-002
008890241779709326-00-001
008890241779569310-10-201
008890241778959310-10-102
008890241778719306-05-070
008890241778649306-05-068
008890241778579306-05-066
008890241778409306-05-064
008890241778339306-05-062
008890241778269306-05-060
008890241778199306-05-058
008890241778029306-05-056
008890241777969306-05-054
008890241777899306-05-052
008890241777729306-05-050
008890241777659306-05-048
008890241777589306-05-046
008890241777419306-05-044
008890241777349306-05-042
008890241777279306-01-004
008890241777109306-01-003
008890241777039306-01-001
008890241776979306-00-003
008890241776809301-10-101
008890241776739301-01-003
008890241776669301-01-001
008890241776599301-00-004
008890241776429301-00-002
008890241776049300-00-001
008890241771859200-99-006
008890241765919200-01-203
008890241669984338-32-067
008890241669814338-32-065
008890241669744338-32-063
008890241669674338-32-061
008890241669504338-32-059
008890241669434338-32-057
008890241669364338-32-055
008890241669294338-32-053
008890241669124338-32-051
008890241669054338-28-067
008890241668994338-28-065
008890241668824338-28-063

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