Vistafix 92998

GUDID 09321502021708

Cochlear™ Vistafix® VXA300 Healing abutment

Cochlear Bone Anchored Solutions AB

Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 09321502021708
• NIH Device Record Key: c6bde21c-068f-4f22-bd44-95fea2a945ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vistafix
• Version Model Number: 92998
• Catalog Number: 92998
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Dimensions

• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0
• Weight: 0.59 Gram
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502021708 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945154

FDA Product Code

• FZE: PROSTHESIS, NOSE, INTERNAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

[09321502021708]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2015-10-22

On-Brand Devices [Vistafix]

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