RANAWAT / BURSTEIN HIP SYSTEM 105859

GUDID 00880304193178

Biomet Orthopedics, LLC

Non-constrained polyethylene acetabular liner
Primary Device ID00880304193178
NIH Device Record Keyace5998b-8c08-471d-bf1d-4a207387810b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRANAWAT / BURSTEIN HIP SYSTEM
Version Model Number105859
Catalog Number105859
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
GS100880304193178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, 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 [RANAWAT / BURSTEIN HIP SYSTEM]

00880304193185105860
00880304193178105859
00880304193161105858
00880304193154105856
00880304193130105854
00880304193116105852
00880304193109105850
00880304193093105849
00880304193086105848
00880304193079105846
00880304193062105844
00880304193055105842
00880304188693104394
00880304188686104393
00880304188679104392
00880304188662104391

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