Sanibel Supply A/S

Basic Information

• Brand Name: Sanibel Supply A/S
• Primary DI: 05711117230512
• Version / Model: Foam ear tip 10 mm, ER10C
• Catalog Number: 8536780
• Company Name: Interacoustics A/S
• Labeler DUNS: 306308354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2025-04-30
• Public Version: 1
• Public Version Date: 2025-05-08
• Public Version Status: New
• Public Device Record Key: 91d603c7-0447-490d-a234-ba176c48fcd1

Device Description

Foam ear tip 10 mm, ER10C

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66677	Vestibulo-auditory analysis system support kit¿	A collection of reusable/consumable devices intended to be used with a vestibulo-auditory analysis system that typically includes two or more of the following: patient electrodes, cables/leads, an ear cup, conductive gel, ear tips and cleaning wipes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05711117244182	GS1
Primary	05711117230512	GS1

Premarket Submissions

Submission Number	Supplement Number
K930553	000