ZCA®

GUDID 00889024144385

Zimmer, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00889024144385
NIH Device Record Key0814cbed-0395-4329-b57e-989e685c7f9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZCA®
Version Model Number8005-260-22
Company DUNS056038268
Company NameZimmer, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024144385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


[00889024144385]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2017-02-09

On-Brand Devices [ZCA®]

008890241444158005-260-32
008890241444088005-260-28
008890241443928005-260-26
008890241443858005-260-22
008890241443618005-250
008890241443478005-210
008890241445148005-300-61
008890241445078005-300-59
008890241444918005-300-57
008890241444848005-300-55
008890241444778005-300-53
008890241444608005-300-51
008890241444538005-300-49
008890241444468005-300-47
008890241444398005-300-45
008890241444228005-300-43
008890241443788005-260
008890241443548005-230
008890241443308005-96
008890241443238005-95
008890241443168005-90
008890241441638000-216
008890241441568000-215
008890241441498000-214
008890243635028005-958-32
008890243634968005-956-32
008890243634898005-954-32
008890243634728005-952-32
008890243634658005-950-32
008890243634588005-948-32
008890243634418005-946-32
008890243628958005-658-32
008890243628888005-658-28
008890243628718005-658-26
008890243628648005-658-22
008890243628578005-656-32
008890243628408005-656-28
008890243628338005-656-26
008890243628268005-656-22
008890243628198005-654-32
008890243628028005-654-28
008890243627968005-654-26
008890243627898005-654-22
008890243627728005-652-32
008890243627658005-652-28
008890243627588005-652-26
008890243627418005-652-22
008890243627348005-650-32
008890243627278005-650-28
008890243627108005-650-26

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