COPELAND SHOULDER SYSTEM 11-114646

GUDID 00880304204805

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis
Primary Device ID00880304204805
NIH Device Record Key7559efd9-9800-453b-9ceb-9c4125a99cee
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOPELAND SHOULDER SYSTEM
Version Model Number11-114646
Catalog Number11-114646
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 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)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304204805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-15
Device Publish Date2015-10-24

On-Brand Devices [COPELAND SHOULDER SYSTEM]

0088030420482911-114648
0088030420481211-114647
0088030420480511-114646
0088030420479911-114645
0088030420478211-114644
0088030420477511-114643
0088030420476811-114642
0088030420475111-114641
0088030420466911-114628
0088030420465211-114627
0088030420464511-114626
0088030420463811-114625
0088030420462111-114624
0088030420461411-114623
0088030420460711-114622
0088030420459111-114621

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