TAPERLOC COMPLETE RASP/PROVISIONAL 51-201185

GUDID 00880304506848

Biomet Orthopedics, LLC

Bone file/rasp, manual Bone file/rasp, manual Bone file/rasp, manual Bone file/rasp, manual
Primary Device ID00880304506848
NIH Device Record Keye8288dfb-053c-4b45-a6e2-5b1f0901ea7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTAPERLOC COMPLETE RASP/PROVISIONAL
Version Model Number51-201185
Catalog Number51-201185
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304506848 [Primary]
GS100880304506848 [Primary]
GS100880304506848 [Primary]
GS100880304506848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304506848]

Moist Heat or Steam Sterilization


[00880304506848]

Moist Heat or Steam Sterilization


[00880304506848]

Moist Heat or Steam Sterilization


[00880304506848]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [TAPERLOC COMPLETE RASP/PROVISIONAL]

0088030463260851-243250
0088030463259251-243240
0088030463258551-243230
0088030463257851-243225
0088030463256151-243220
0088030463255451-243210
0088030463254751-243200
0088030463253051-243190
0088030463252351-243185
0088030463251651-243180
0088030463250951-243175
0088030463249351-243170
0088030463248651-243160
0088030463247951-243150
0088030463246251-243140
0088030463245551-243135
0088030463244851-243130
0088030463243151-243125
0088030463242451-243120
0088030463241751-243110
0088030463240051-243100
0088030463239451-243090
0088030463238751-243080
0088030463237051-243075
0088030463236351-243070
0088030463235651-243060
0088030463234951-243050
0088030463233251-243040
0088030463222651-203250
0088030463221951-203230
0088030463220251-203225
0088030463219651-203210
0088030463218951-203190
0088030463217251-203185
0088030463216551-203175
0088030463215851-203135
0088030463214151-203125
0088030463213451-203080
0088030463212751-203075
0088030463211051-203070
0088030463210351-203060
0088030463209751-203050
0088030463208051-203040
00880304569270110010894
00880304569263110010893
00880304569256110010892
00880304569249110010891
00880304569232110010890
00880304569225110010889
00880304569218110010888

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