RINGLOC HIP SYSTEM XL-166236

GUDID 00880304651845

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304651845
NIH Device Record Keyb69e3a44-597b-45af-8344-aed5af7e9e40
Commercial Distribution StatusIn Commercial Distribution
Brand NameRINGLOC HIP SYSTEM
Version Model NumberXL-166236
Catalog NumberXL-166236
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
GS100880304651845 [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

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00880304651579XL-108428
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00880304651548XL-108425
00880304651531XL-108424
00880304651524XL-108323
00880304651517XL-108322
00880304651500XL-108321
00880304651494XL-108223
00880304651487XL-108222
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00880304651463XL-107928
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