BIOLOX DELTA HIP SYSTEM 12-115134

GUDID 05019279316182

Biomet Orthopedics, LLC

Radio-frequency ablation system generator
Primary Device ID05019279316182
NIH Device Record Key06398a1f-a899-4c3a-a3d5-872ebee51096
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOLOX DELTA HIP SYSTEM
Version Model Number12-115134
Catalog Number12-115134
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.c
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS105019279316182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, 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 [BIOLOX DELTA HIP SYSTEM]

0088030459163912-115123
0088030459162212-115122
0088030459161512-115121
0088030459160812-115120
0088030459158512-115109
00880304521957650-1057
00880304521933650-1058
00880304521896650-1056
00880304510562650-1059
0088030444882712-115110
0088030443880412-115115
0088030443853812-115116
0088030443839212-115117
0088030443754812-115111
0088030443403512-115114
0501927931618212-115134
0501927931617512-115133
0501927931616812-115132
0501927931615112-115131
0501927931614412-115130

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.