AFFIXUS®CORTICAL BONE SCREW 814550070

GUDID 00887868039621

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00887868039621
NIH Device Record Keya0981789-a47d-4dc1-a167-b53ff6900f1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFFIXUS®CORTICAL BONE SCREW
Version Model Number8145-50-070
Catalog Number814550070
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
Phone+1(800)348-9500
Emailcustomerservice@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100887868039621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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 [AFFIXUS®CORTICAL BONE SCREW]

008878680396458145-50-080
008878680396388145-50-075
008878680396218145-50-070
008878680396148145-50-065
008878680396078145-50-060
008878680395918145-50-058
008878680395848145-50-056
008878680395778145-50-054
008878680395608145-50-052
008878680395538145-50-050
008878680395468145-50-048
008878680395398145-50-046
008878680395228145-50-044
008878680395158145-50-042
008878680395088145-50-040
008878680394928145-50-038
008878680394858145-50-036
008878680394788145-50-034
008878680394618145-50-032
008878680394548145-50-030
008878680394478145-50-028
008878680394308145-50-026
008878680394238145-50-024
008878680394168145-50-022
008878680394098145-50-020

Trademark Results [AFFIXUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AFFIXUS
AFFIXUS
77944955 3912289 Live/Registered
BIOMET C.V.
2010-02-25

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