REGENEREX RINGLOC + HIP SYSTEM PT-106046

GUDID 00880304649064

Biomet Orthopedics, LLC

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID00880304649064
NIH Device Record Keyff31bb5d-cd66-4d1b-81a6-e03bfa3c20c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGENEREX RINGLOC + HIP SYSTEM
Version Model NumberPT-106046
Catalog NumberPT-106046
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100880304649064 [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 [REGENEREX RINGLOC + HIP SYSTEM]

00880304649088PT-106052
00880304649071PT-106048
00880304649064PT-106046
00880304649057PT-106044
00880304477520PT-106050
00880304460423PT-106080
00880304460416PT-106078
00880304460409PT-106076
00880304460393PT-106074
00880304460348PT-104072
00880304460249PT-116046
00880304460232PT-116044
00880304459861PT-116042
00880304455191PT-104048
00880304455184PT-104050
00880304455160PT-104064
00880304455153PT-104058
00880304455146PT-104052
00880304455139PT-104056
00880304455122PT-104066
00880304455115PT-104054
00880304455108PT-104060
00880304455092PT-104062
00880304455023PT-106072
00880304455016PT-106070
00880304455009PT-106068
00880304454996PT-106066
00880304454989PT-106064
00880304454972PT-106060
00880304454965PT-106062
00880304454958PT-106058
00880304454941PT-106056
00880304454934PT-106054
00880304451506PT-116066
00880304451490PT-116064
00880304451483PT-116048
00880304451476PT-116060
00880304451469PT-116058
00880304451452PT-116054
00880304451445PT-116052
00880304451438PT-116056
00880304451421PT-116062
00880304451414PT-116050
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