EXACT/ALLIANCE INSTRUMENTS 31-400320

GUDID 00880304536678

Biomet Orthopedics, LLC

Bone file/rasp, manual Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable Bone file/rasp, manual, reusable
Primary Device ID00880304536678
NIH Device Record Key0c491e08-5bab-4cab-b1f6-8b4b021ef578
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXACT/ALLIANCE INSTRUMENTS
Version Model Number31-400320
Catalog Number31-400320
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
GS100880304536678 [Primary]

FDA Product Code

HTQBROACH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

Moist Heat or Steam Sterilization


[00880304536678]

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

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