Field Bone-Anchored Drill Kit 91053R

GUDID 09321502030434

Cochlear Americas Corporation

Bone-conduction hearing implant system implantation tool
Primary Device ID09321502030434
NIH Device Record Key3678bdda-04da-439f-b2d9-591bbfece747
Commercial Distribution StatusIn Commercial Distribution
Brand NameField Bone-Anchored Drill Kit
Version Model Number91053R
Catalog Number91053R
Company DUNS130866817
Company NameCochlear Americas Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS109321502030434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXBHearing aid, bone conduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

Devices Manufactured by Cochlear Americas Corporation

09321502074117 - BAHA FITTING SOFTWARE 5 CD2024-01-11
09321502074124 - BAHA FITTING SOFTWARE 6 CD2024-01-11
09321502074131 - OSIA FITTING SOFTWARE 2 CD2024-01-11
09321502074148 - CUSTOM SOUND PRO 7.0 CD2024-01-11
09321502030434 - Field Bone-Anchored Drill Kit2023-07-04
09321502030434 - Field Bone-Anchored Drill Kit2023-07-04
09321502070690 - Rental Bone-Anchored Drill Kit2023-07-04

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