COMPREHENSIVE SRS INSTRUMENT 405132

GUDID 00880304541856

Biomet Orthopedics, LLC

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Primary Device ID00880304541856
NIH Device Record Keyc3c7aa76-6850-40ab-9e70-b84f78d94b50
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPREHENSIVE SRS INSTRUMENT
Version Model Number405132
Catalog Number405132
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
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304541856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


[00880304541856]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-10-27

On-Brand Devices [COMPREHENSIVE SRS INSTRUMENT]

00880304542624405110
00880304542396405180
00880304542358405181
00880304542334405219
00880304542310405199
00880304542303405201
00880304542297405204
00880304542280405104
00880304542266405168
00880304542259405130
00880304542242405207
00880304542235405106
00880304542211405108
00880304542204405116
00880304542198405173
00880304542181405112
00880304542150405122
00880304542143405171
00880304542112405195
00880304542105405117
00880304542075405107
00880304542068405196
00880304542051405109
00880304542044405111
00880304542037405118
00880304542020405119
00880304542013405169
00880304542006405177
00880304541986405113
00880304541955405203
00880304541900405227
00880304541894405121
00880304541887405210
00880304541870405102
00880304541863405105
00880304541856405132
00880304541849405172
00880304541832405123
00880304541825405125
00880304541818405141
00880304541801405137
00880304541795405138
00880304541788405212
00880304541771405213
00880304541764405143
00880304541757405175
00880304541740405135
00880304541733405214
00880304541726405218
00880304541719405133

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