REGENEREX HIP SYSTEM PT-210352

GUDID 00880304450219

Biomet Orthopedics, LLC

Metallic acetabulum prosthesis
Primary Device ID00880304450219
NIH Device Record Key8298c1cd-c9e0-4368-b779-53ed54ac8684
Commercial Distribution StatusIn Commercial Distribution
Brand NameREGENEREX HIP SYSTEM
Version Model NumberPT-210352
Catalog NumberPT-210352
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
GS100880304450219 [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 [REGENEREX HIP SYSTEM]

00880304453807PT-124252
00880304450257PT-210152
00880304450240PT-210154
00880304450233PT-210358
00880304450226PT-210156
00880304450219PT-210352
00880304450202PT-210354
00880304450196PT-210258
00880304450189PT-210256
00880304450172PT-210356
00880304450165PT-210252
00880304450158PT-210158
00880304450141PT-210254
00880304449350PT-126474
00880304449343PT-125060
00880304449336PT-124858
00880304449329PT-124454
00880304449312PT-125262
00880304449305PT-124656
00880304449299PT-125464
00880304449282PT-126676
00880304449275PT-125666
00880304449268PT-126070
00880304449251PT-126272
00880304449244PT-125868

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