SoftWear Pad P793402

GUDID 09321502036764

SoftWear™ Pad

COCHLEAR LIMITED

Hearing implant system sound processor pad
Primary Device ID09321502036764
NIH Device Record Keybe06d71f-c392-4a27-ba61-354ad3babd06
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftWear Pad
Version Model NumberP793402
Catalog NumberP793402
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502036764 [Primary]
GS109321502040525 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-07-28
Device Publish Date2016-10-13

On-Brand Devices [SoftWear Pad]

09321502036771SoftWear™ Pad
09321502036764SoftWear™ Pad

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