EXACT/ALLIANCE INSTRUMENTS 31-400318

GUDID 00880304536685

Biomet Orthopedics, LLC

Bone file/rasp, manual
Primary Device ID00880304536685
NIH Device Record Keya9051972-2c96-4231-ab5c-0e8dfd9cbe83
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXACT/ALLIANCE INSTRUMENTS
Version Model Number31-400318
Catalog Number31-400318
Company DUNS129278169
Company NameBiomet Orthopedics, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304536685 [Primary]

FDA Product Code

HTQBROACH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


[00880304536685]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-12-07
Device Publish Date2017-07-28

On-Brand Devices [EXACT/ALLIANCE INSTRUMENTS]

0088030453668531-400318
0088030453667831-400320
0088030453666131-400321
0088030446305931-400309

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