Cochlear™ Slim Modiolar Electrode Sheath

Basic Information

• Brand Name: Cochlear™ Slim Modiolar Electrode Sheath
• Primary DI: 09321502043564
• Version / Model: P1291522
• Catalog Number: P1291522
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 2
• Public Version Date: 2022-02-24
• Public Version Status: Update
• Public Device Record Key: 19d4425d-9fdc-42b4-96ea-059419db4b04

Device Description

N/A

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63161	Cochlear electrode array introducer, single-use	A sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin shaft onto which the electrode is distally mounted and then advanced into the cochlea by means of a manually-operated sliding mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502043564	GS1

Customer Contacts

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