Vistafix 93100
GUDID 09321502021715
Cochlear™ Vistafix® VXI300 Implant 3mm
Cochlear Bone Anchored Solutions AB
Craniofacial bone screw, non-bioabsorbable| Primary Device ID | 09321502021715 |
| NIH Device Record Key | e1ce3770-4c02-4377-8540-c5fb229bd718 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vistafix |
| Version Model Number | 93100 |
| Catalog Number | 93100 |
| 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 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com |
Device Dimensions
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
| Length | 3 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502021715 [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 |
[09321502021715]
Radiation Sterilization
[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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[09321502021715]
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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 |
Trademark Results [Vistafix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISTAFIX 78574040 3238112 Live/Registered |
COCHLEAR BONE ANCHORED SOLUTIONS AB 2005-02-24 |
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