Regenerex® 184603

GUDID 00887868252235

Biomet Orthopedics, LLC

Knee arthroplasty wedge
Primary Device ID00887868252235
NIH Device Record Key9378ee9f-0901-4180-b51b-3194c9d0c33c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegenerex®
Version Model Number184603
Catalog Number184603
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
GS100887868252235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

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 [Regenerex®]

00887868252280184608
00887868252273184607
00887868252266184606
00887868252259184605
00887868252242184604
00887868252235184603
00887868252228184602
00887868252211184601
00887868252204141269

Trademark Results [Regenerex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REGENEREX
REGENEREX
78753529 3331701 Live/Registered
Biomet Manufacturing, LLC
2005-11-14

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