ADHEAR Adhesive Adapters, beige, 15 pcs.

Basic Information

• Brand Name: ADHEAR Adhesive Adapters, beige, 15 pcs.
• Primary DI: 09008737346898
• Version / Model: 34689
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2018-06-27
• Public Version: 3
• Public Version Date: 2022-09-15
• Public Version Status: Update
• Public Device Record Key: 63e09115-5c4c-4806-b476-1f7951c5322b

Device Description

Audio Processor Adhesive Adapters

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: 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: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
64775	Head-worn bone-conduction hearing aid holder, single-use	A device intended to be fixed/worn on a patient’s head to hold a head-worn bone-conduction hearing aid. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat) or worn like a headband. It may include dedicated devices (e.g., scale) used in the fitting process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737346898	GS1
Unit of Use	09008737345761	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172460	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store the Adhesive Adapters in a dry place at room temperature.
• Type: Storage Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 50 – 80 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 27 Degrees Celsius