PS CONSTRAINED INSERT XSM 178828

GUDID 08428898186071

BIOMET SPAIN ORTHOPAEDICS SL

Tibial insert
Primary Device ID08428898186071
NIH Device Record Keyf1df5512-ed10-43f2-87fb-629a815d2c95
Commercial Distribution StatusIn Commercial Distribution
Brand NamePS CONSTRAINED INSERT XSM
Version Model Number178828
Catalog Number178828
Company DUNS460900553
Company NameBIOMET SPAIN ORTHOPAEDICS SL
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)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@zimmerbiomet.com
Phone+1(800)342-5454
Email3iPBG-CS@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
GS108428898186071 [Primary]

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-10
Device Publish Date2016-03-11

On-Brand Devices [PS CONSTRAINED INSERT XSM]

08428898186088178832
08428898186071178828
08428898186064178825
08428898186057178822
08428898186040178820

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