Vistafix 93101

GUDID 09321502021722

Cochlear™ Vistafix® VXI300 Implant 4mm

Cochlear Bone Anchored Solutions AB

Craniofacial bone screw, non-bioabsorbable
Primary Device ID09321502021722
NIH Device Record Key66197e29-4103-4522-9aa9-5d4a3f99fb6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVistafix
Version Model Number93101
Catalog Number93101
Company DUNS559784736
Company NameCochlear Bone Anchored Solutions AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com

Device Dimensions

Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
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Length4 Millimeter
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Length4 Millimeter
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Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter
Device Size Text, specify0
Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502021722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FZEPROSTHESIS, NOSE, INTERNAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


[09321502021722]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-10-22

On-Brand Devices [Vistafix]

09321502021739Cover screw conical for Vistafix® VXI300 Implant
09321502021722Cochlear™ Vistafix® VXI300 Implant 4mm
09321502021715Cochlear™ Vistafix® VXI300 Implant 3mm
09321502021708Cochlear™ Vistafix® VXA300 Healing abutment
09321502021692Cochlear™ Vistafix® VXA300 Abutment 7.5mm
09321502021685Cochlear™ Vistafix® VXA300 Abutment 6mm
09321502021678Cochlear™ Vistafix® VXA300 Abutment 4.5mm
09321502021661Cochlear™ Vistafix® VXA300 Abutment 3.5mm

Trademark Results [Vistafix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISTAFIX
VISTAFIX
78574040 3238112 Live/Registered
COCHLEAR BONE ANCHORED SOLUTIONS AB
2005-02-24

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