RINGLOC MALLORY HEAD HIP SYSTEM 13-104146

GUDID 00880304226838

Biomet Orthopedics, LLC

Metallic femoral head prosthesis
Primary Device ID00880304226838
NIH Device Record Key58823a5d-14ab-40f4-a7c7-90da83bfacd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRINGLOC MALLORY HEAD HIP SYSTEM
Version Model Number13-104146
Catalog Number13-104146
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
GS100880304226838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, 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 [RINGLOC MALLORY HEAD HIP SYSTEM]

0088030422703313-104180
0088030422702613-104178
0088030422701913-104176
0088030422700213-104174
0088030422699913-104172
0088030422698213-104170
0088030422697513-104168
0088030422696813-104166
0088030422695113-104164
0088030422694413-104162
0088030422693713-104160
0088030422692013-104158
0088030422691313-104156
0088030422689013-104154
0088030422688313-104152
0088030422687613-104150
0088030422685213-104148
0088030422683813-104146
0088030422682113-104144
0088030422681413-104142
0088030422680713-104140
0088030422679113-104080
0088030422678413-104078
0088030422677713-104076
0088030422676013-104074
0088030422675313-104072
0088030422674613-104070
0088030422673913-104068
0088030422672213-104066
0088030422671513-104064
0088030422670813-104062
0088030422669213-104060
0088030422668513-104058
0088030422666113-104056
0088030422664713-104054
0088030422663013-104052
0088030422662313-104050
0088030422660913-104048
0088030422659313-104046
0088030422658613-104044
0088030422657913-104042
0088030422656213-104040
0088030421999112-104180
0088030421998412-104178
0088030421997712-104176
0088030421996012-104174
0088030421995312-104172
0088030421994612-104170
0088030421992212-104168
0088030421991512-104166

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