SoftWear Pad

Basic Information

• Brand Name: SoftWear Pad
• Primary DI: 09321502036764
• Version / Model: P793402
• Catalog Number: P793402
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 4
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: be06d71f-c392-4a27-ba61-354ad3babd06

Device Description

SoftWear™ Pad

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
65086	Hearing implant system sound processor pad	A thin layer of foam intended to be adhered to the inner side of a hearing implant system sound processor (not included) to provide supplemental stability and comfort to the wearer of the sound processor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502036764	GS1
Unit of Use	09321502040525	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970051	143