REACH MODULAR HIP SYSTEM 108393

GUDID 00880304196674

Biomet Orthopedics, LLC

Coated femoral stem prosthesis, modular
Primary Device ID00880304196674
NIH Device Record Keyb0b75dad-6cbc-4bb2-ac21-d903528ace33
Commercial Distribution StatusIn Commercial Distribution
Brand NameREACH MODULAR HIP SYSTEM
Version Model Number108393
Catalog Number108393
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
GS100880304196674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

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 MODULAR HIP SYSTEM]

0088030428212421-108399
0088030428211721-108397
0088030428210021-108393
0088030428209421-108391
0088030428208721-108293
0088030428207021-108291
00880304196728108401
00880304196711108399
00880304196704108397
00880304196681108395
00880304196674108393
00880304196667108391
00880304196476108301
00880304196452108295
00880304196438108293
00880304196421108291
00880304009530108299
0088030400903521-108395
0088030400767321-108297
0088030400566221-108299
0088030400329321-108295
00880304000131108297

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