AFFIXUS®HIP FRACTURE NAIL 814309180

GUDID 00887868037962

Biomet Orthopedics, LLC

Femur nail, sterile
Primary Device ID00887868037962
NIH Device Record Keyc2a3cc5e-c4cc-4a59-8084-cac1975087d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAFFIXUS®HIP FRACTURE NAIL
Version Model Number8143-09-180
Catalog Number814309180
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
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS100887868037962 [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]

008878680392498145-13-180
008878680391028145-11-180
008878680388468145-09-180
008878680382048143-13-180
008878680380828143-11-180
008878680379628143-09-180

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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