PRELUDE PATELLO-FEMORAL SYSTEM 110004113

GUDID 00880304566941

Biomet Orthopedics, LLC

Orthopaedic implant aiming/guiding block, reusable
Primary Device ID00880304566941
NIH Device Record Key8fea288c-cdcf-47e2-b79b-277947c85ad1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRELUDE PATELLO-FEMORAL SYSTEM
Version Model Number110004113
Catalog Number110004113
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
GS100880304566941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304566941]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-28

On-Brand Devices [PRELUDE PATELLO-FEMORAL SYSTEM]

00880304738386010001740
00880304738379010001738
00880304738362010001736
00880304738355010001734
00880304738348010001732
00880304738331010001730
00880304738324010001724
00880304738317010001722
00880304738300010001720
00880304738294010001716
00880304738287010001714
00880304738270010001712
00880304738263010001710
00880304738256010001708
00880304738249010001706
00880304680302110018821
00880304680296110018820
00880304567597110004345
00880304567580110004344
00880304567573110004343
00880304567566110004342
00880304567559110004341
00880304567542110004340
00880304567535110004339
00880304567528110004338
00880304567511110004337
00880304567443110004264
00880304567436110004262
00880304567429110004260
00880304567412110004258
00880304567405110004256
00880304567399110004254
00880304567382110004252
00880304567375110004250
00880304567368110004248
00880304567283110004172
00880304567238110004165
00880304567139110004151
00880304567030110004122
00880304567023110004121
00880304567016110004120
00880304567009110004119
00880304566996110004118
00880304566989110004117
00880304566972110004116
00880304566965110004115
00880304566958110004114
00880304566941110004113
00880304566934110004112
00880304566927110004111

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.