LOCKNUT, CORTICAL 805035000

GUDID 00887868033483

Biomet Orthopedics, LLC

Orthopaedic bone nut
Primary Device ID00887868033483
NIH Device Record Keyf0322b47-20eb-4d40-b240-78e1ab0516b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOCKNUT, CORTICAL
Version Model Number8050-35-000
Catalog Number805035000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100887868033483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWASHER, BOLT NUT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [LOCKNUT, CORTICAL]

008878680340848050-65-000
008878680336058050-45-000
008878680334838050-35-000

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