4366-32-067

GUDID 00889024644229

Zimmer, Inc.

Non-constrained polyethylene acetabular liner
Primary Device ID00889024644229
NIH Device Record Keyaaae9f6e-ebf0-40bb-97ec-bb82884937a2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4366-32-067
Catalog Number4366-32-067
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@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
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

Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter
Lumen/Inner Diameter32 Millimeter
Outer Diameter67 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024644229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-07
Device Publish Date2022-02-25

Devices Manufactured by Zimmer, Inc.

00887868585661 - Zimmer Biomet® 12/14 Spherical Head Trials2024-11-19
00887868139628 - Affixus®2024-11-18
00887868139635 - Affixus®2024-11-18
00887868139642 - Affixus®2024-11-18
00887868139659 - Affixus®2024-11-18
00887868139666 - Affixus®2024-11-18
00887868139673 - Affixus®2024-11-18
00887868139680 - Affixus®2024-11-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.