ISO adapter for Surgical wrench 92353

GUDID 09321502019804

N/A

Cochlear Bone Anchored Solutions AB

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: 09321502019804
• NIH Device Record Key: 42fbe6dc-9ad4-4507-a89f-be7984521ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISO adapter for Surgical wrench
• Version Model Number: 92353
• Catalog Number: 92353
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502019804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955713

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: 2021-09-14
• Device Publish Date: 2017-06-07

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• 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)