REACH REVISION HIP SYSTEM 11-162116

GUDID 00880304208490

Biomet Orthopedics, LLC

Revision coated hip femur prosthesis
Primary Device ID00880304208490
NIH Device Record Key6fdbc7f1-fdd4-41de-9866-fc6e960700cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameREACH REVISION HIP SYSTEM
Version Model Number11-162116
Catalog Number11-162116
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
GS100880304208490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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 [REACH REVISION HIP SYSTEM]

00880304251632162120
00880304251625162119
00880304251618162118
00880304251601162117
00880304251595162116
00880304251588162115
00880304251571162114
00880304251557162113
00880304251540162112
00880304251533162111
0088030422263212-162119
0088030422262512-162117
0088030422261812-162115
0088030422260112-162113
0088030422259512-162111
0088030420850611-162120
0088030420849011-162116
0088030420848311-162115
0088030420847611-162114
0088030420845211-162113
0088030420844511-162112
0088030420843811-162111
0088030400787111-162119
0088030400786411-162117
0088030400057511-162118

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