SoftWear Pad P793406

GUDID 09321502036771

SoftWear™ Pad

COCHLEAR LIMITED

Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad Hearing implant system sound processor pad

• Primary Device ID: 09321502036771
• NIH Device Record Key: 8437378c-31bf-4f3f-aea2-271727ecab68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SoftWear Pad
• Version Model Number: P793406
• Catalog Number: P793406
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502036771 [Primary]
GS1	09321502040532 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051

FDA Product Code

• MCM: IMPLANT, COCHLEAR

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: 2023-07-28
• Device Publish Date: 2016-10-13

On-Brand Devices [SoftWear Pad]

• 09321502036771: SoftWear™ Pad
• 09321502036764: SoftWear™ Pad