AFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW 814501050

GUDID 00887868038655

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00887868038655
NIH Device Record Key434dae04-640d-4c0b-b7da-0eccd051b437
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW
Version Model Number8145-01-050
Catalog Number814501050
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
GS100887868038655 [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®HIP FRACTURE NAIL ANTI-ROTATION SCREW]

008878680387788145-01-110
008878680387618145-01-105
008878680387548145-01-100
008878680387478145-01-095
008878680387308145-01-090
008878680387238145-01-085
008878680387168145-01-080
008878680387098145-01-075
008878680386938145-01-070
008878680386868145-01-065
008878680386798145-01-060
008878680386628145-01-055
008878680386558145-01-050

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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