Echo FX™ Hip System 192518

GUDID 00887868260933

Biomet Orthopedics, LLC

Press-fit femoral stem prosthesis
Primary Device ID00887868260933
NIH Device Record Key5d572ae5-d0aa-46be-a79c-007b23f6cfeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEcho FX™ Hip System
Version Model Number192518
Catalog Number192518
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
GS100887868260933 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWLProsthesis, hip, hemi-, femoral, metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-23
Device Publish Date2018-07-23

On-Brand Devices [Echo FX™ Hip System]

0088786826113812-151317
0088786826112112-151315
0088786826111412-151313
0088786826110712-151311
0088786826109112-151309
0088786826108412-151307
00887868260964192521
00887868260957192520
00887868260940192519
00887868260933192518
00887868260926192517
00887868260919192516

Trademark Results [Echo FX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ECHO FX
ECHO FX
88884532 not registered Live/Pending
LifePro Fitness LLC
2020-04-23
ECHO FX
ECHO FX
85376278 not registered Dead/Abandoned
Biomet Manufacturing Corp.
2011-07-20

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