HYBRID(TM) GLENOID 406112

GUDID 00880304456358

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable
Primary Device ID00880304456358
NIH Device Record Key268ab9d5-bb7f-46fe-8ecc-4182b2a4a8e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYBRID(TM) GLENOID
Version Model Number406112
Catalog Number406112
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
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 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)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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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
GS100880304456358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


[00880304456358]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-03-20

On-Brand Devices [HYBRID(TM) GLENOID]

00880304456358406112
00880304456341406114
00880304456334406113

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