Field Bone-Anchored Drill Kit 91053R

GUDID 09321502030434

Cochlear Americas Corporation

Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool Bone-conduction hearing implant system implantation tool

• Primary Device ID: 09321502030434
• NIH Device Record Key: 3678bdda-04da-439f-b2d9-591bbfece747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Field Bone-Anchored Drill Kit
• Version Model Number: 91053R
• Catalog Number: 91053R
• Company DUNS: 130866817
• Company Name: Cochlear Americas Corporation
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502030434 [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: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by Cochlear Americas Corporation

• 09321502074117 - BAHA FITTING SOFTWARE 5 CD: 2024-01-11
• 09321502074124 - BAHA FITTING SOFTWARE 6 CD: 2024-01-11
• 09321502074131 - OSIA FITTING SOFTWARE 2 CD: 2024-01-11
• 09321502074148 - CUSTOM SOUND PRO 7.0 CD: 2024-01-11
• 09321502030434 - Field Bone-Anchored Drill Kit: 2023-07-04
• 09321502030434 - Field Bone-Anchored Drill Kit: 2023-07-04
• 09321502070690 - Rental Bone-Anchored Drill Kit: 2023-07-04