32-8105-038-00

GUDID 00889024274082

Zimmer, Inc.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile
Primary Device ID00889024274082
NIH Device Record Key923e6de2-feb7-448d-b576-9f7da51d5996
Commercial Distribution StatusIn Commercial Distribution
Version Model Number32-8105-38
Catalog Number32-8105-038-00
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
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

Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter
Outer Diameter25 Millimeter
Device Size Text, specify0
Outer Diameter16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024274082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-07-19
Device Publish Date2016-08-09

Devices Manufactured by Zimmer, Inc.

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00889024648197 - ROSA® Shoulder2024-02-29
00889024648203 - ROSA® Shoulder2024-02-29
00889024625877 - G7 25MM DRILL GUIDE2023-12-25
00889024657441 - RDCTN HNDL ASSY LRG2023-12-25
00889024658004 - PIVOTING HUMERAL EM GUIDE2023-12-25
00889024660571 - 3.5MM BALL HEX SHAFT2023-12-25
00889024661257 - REAMER ADPT PULLER2023-12-25

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