Baha 90427

GUDID 09321502014380

Console abutment 60° Unigrip

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: 09321502014380
• NIH Device Record Key: 71582915-687d-4375-b41d-628065871b7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha
• Version Model Number: 90427
• Catalog Number: 90427
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	09321502014380 [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

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

Radiation Sterilization

[09321502014380]

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

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