REGENEREX 184607

GUDID 00880304461932

Biomet Orthopedics, LLC

Knee arthroplasty wedge
Primary Device ID00880304461932
NIH Device Record Key8f50395e-074c-46f1-9176-4a608275702c
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGENEREX
Version Model Number184607
Catalog Number184607
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
GS100880304461932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

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 [REGENEREX]

00880304479920141269
00880304478145141277
0088030447494932-484620
0088030447265532-484626
0088030447147432-484606
0088030447146732-484602
0088030447145032-484605
0088030447144332-484607
0088030447143632-484603
0088030447142932-484608
0088030447141232-484601
0088030447140532-484604
0088030447138232-484625
0088030446823832-484623
0088030446822132-484624
0088030446821432-484627
0088030446820732-484622
0088030446819132-484628
00880304467088184601
00880304467057184605
00880304463646141273
00880304463639141276
00880304463622141271
00880304463615141272
00880304463608141275
00880304463592141270
00880304463585141274
00880304461970184602
00880304461963184603
00880304461956184604
00880304461949184606
00880304461932184607
00880304461925184608
00889024521018SSI001041
00880304554429141357
00880304554412141356
00880304554405141355
00880304506084141358
0088030447139932-484615

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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