COMPREHENSIVE SHOULDER SYSTEM 11-113554

GUDID 00880304441842

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis
Primary Device ID00880304441842
NIH Device Record Key36d34834-c71a-4b93-94a1-d279a654c60a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE SHOULDER SYSTEM
Version Model Number11-113554
Catalog Number11-113554
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
GS100880304441842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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 [COMPREHENSIVE SHOULDER SYSTEM]

00880304849631SSI001963
00880304849624SSI001964
00880304849617SSI001965
00880304849600SSI001765
00880304849594SSI001761
00880304849587SSI001757
00880304849570SSI000168
00880304849563SSI000167
00880304849556SSI000166
00880304681156TI-113067
00880304681149TI-113065
00880304681125TI-113057
00880304681101TI-113053
00880304681095TI-113048
00880304681088TI-113046
00880304681071TI-113044
00880304681064TI-113042
00880304681057TI-113036
00880304681040TI-113034
00880304681033TI-113032
00880304681026TI-113024
00880304681019TI-113022
00880304677432180577
00880304677425180576
00880304677418180575
00880304677401180574
00880304677395180573
00880304677388180572
00880304677371180571
00880304677364180570
00880304677357180569
00880304677340180568
00880304677333180567
00880304677326180566
00880304677319180565
00880304677302180564
00880304673816110017161
00880304673809110017162
00880304650152TI-113055
0088030462832841-405820
0088030462831141-405819
0088030462830441-405818
0088030462829841-405817
0088030462828141-405816
0088030462827441-405815
0088030462826741-405814
0088030462825041-405813
0088030462824341-405812
0088030462823641-405811
0088030462822941-405810

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