Abutment Inserter P1582229

GUDID 09321502045032

Cochlear Bone Anchored Solutions AB

General external orthopaedic fixation system implantation kit, reusable

• Primary Device ID: 09321502045032
• NIH Device Record Key: 4b4449a4-6228-4463-a052-e306b0bf19c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment Inserter
• Version Model Number: P1582229
• Catalog Number: P1582229
• 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: true
• 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
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502045032 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-23
• Device Publish Date: 2023-05-15

Devices Manufactured by Cochlear Bone Anchored Solutions AB

• 09321502020848 - Irrigation Tubing Set 3,8 m: 2024-12-12
• 09321502019651 - Baha: 2024-09-19 Abutment instrument set
• 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)