ZCA®

GUDID 00889024363472

Zimmer, Inc.

Polyethylene acetabulum prosthesis
Primary Device ID00889024363472
NIH Device Record Keyf532bd37-96ac-4a0d-88da-e985bdc8a221
Commercial Distribution StatusIn Commercial Distribution
Brand NameZCA®
Version Model Number8005-952-32
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
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
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0
Lumen/Inner Diameter32 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024363472 [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 Date2017-07-17

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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