Cochlear™ CP1110S Surgical Coil, 2m

Basic Information

• Brand Name: Cochlear™ CP1110S Surgical Coil, 2m
• Primary DI: 09321502073110
• Version / Model: 2m
• Catalog Number: P1998830
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-07
• Public Version: 1
• Public Version Date: 2025-07-15
• Public Version Status: New
• Public Device Record Key: de4d9914-09b0-48fb-a1b2-b62ac72e10fe

Device Description

Hearing Implant Accessory

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
64984	Cochlear implant intraoperative electrophysiological transceiver	A noninvasive, electrically-powered device designed to wirelessly receive electrophysiological data (e.g., impedance, neural response) from the electrode array assembly of a cochlear implant system during implantation, and wirelessly transmit the data in real-time to an off-the-shelf computer/tablet with appropriate software installed. The data is intended for intraoperative analysis of the placement and in situ function of the implanted electrode array.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502073110	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	225