Baha

Basic Information

• Brand Name: Baha
• Primary DI: 09321502019675
• Version / Model: 92146
• Catalog Number: 92146
• Company Name: Cochlear Bone Anchored Solutions AB
• Labeler DUNS: 559784736
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-07
• Public Version: 3
• Public Version Date: 2018-12-24
• Public Version Status: Update
• Public Device Record Key: 33e3d57b-f053-47d7-8e72-09a71003c599

Device Description

Baha instrument organiser

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: No
• 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
LXB	Hearing aid, bone conduction	Ear, Nose, Throat	874.3302	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35124	Medical device integration rack	A device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502019675	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955713	000