Test Rod 92612

GUDID 09321502034371

Cochlear Bone Anchored Solutions AB

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502034371
• NIH Device Record Key: 4a837ed9-51ec-42d4-b6d2-b8f0f0ca2f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Test Rod
• Version Model Number: 92612
• Catalog Number: 92612
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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	09321502034371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090720

FDA Product Code

• LXB: Hearing aid, bone conduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-27
• Device Publish Date: 2017-06-07

Devices Manufactured by Cochlear Bone Anchored Solutions AB

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• 09321502034654 - Baha: 2023-11-29 Baha 5 Power Battery door
• 09321502040174 - Baha: 2023-11-29 BP110 Power battery doors Apple Green
• 09321502040181 - Baha: 2023-11-29 BP110 Power battery doors Ocean Blue
• 09321502040198 - Baha: 2023-11-29 BP110 Power battery doors Iris Purple
• 09321502040204 - Baha: 2023-11-29 BP110 Power battery doors Ruby Red
• 09321502040259 - Baha: 2023-11-29 Inner Case BP110 (Spare part)