ECHO FX HIP SYSTEM 12-151415

GUDID 00880304520301

Biomet Orthopedics, LLC

Uncoated femoral stem prosthesis, one-piece
Primary Device ID00880304520301
NIH Device Record Keybe521db3-a579-47fa-8381-a7212a93eef7
Commercial Distribution StatusIn Commercial Distribution
Brand NameECHO FX HIP SYSTEM
Version Model Number12-151415
Catalog Number12-151415
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
GS100880304520301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

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 [ECHO FX HIP SYSTEM]

0088030452032512-151417
0088030452031812-151413
0088030452030112-151415
0088030452029512-151409
0088030452028812-151411
0088030446794112-151313
0088030446793412-151315
0088030446792712-151317
0088030446791012-151307
0088030446416212-151311
0088030445758412-151309

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