INTEGRATED SHOULDER SYSTEM 490411125

GUDID 00880304387447

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis
Primary Device ID00880304387447
NIH Device Record Key4f82dc30-1bd5-4c38-8be0-a3a4245100f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRATED SHOULDER SYSTEM
Version Model Number490411125
Catalog Number490411125
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
GS100880304387447 [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 Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [INTEGRATED SHOULDER SYSTEM]

00880304387478490715125
00880304387461490614125
00880304387454490512125
00880304387447490411125
00880304387430490207125
00880304387423490106125
00880304378209450732051
00880304378186450628049
00880304378179450422045
00880304378155450320043
00880304378117450115038
00880304377028441000010
0088030419591210804
0088030419584410801
00880304008755490309125
00880304008748450524047
00880304008731450217041
0088030400513610805
0088030400487010803

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