BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Sanibel Supply A/S

DI: 05711117230499 · Model: Foam ear tip 10 mm, ER1/ER2 · Interacoustics A/S

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

50

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Basic Information

Brand Name: Sanibel Supply A/S
Primary DI: 05711117230499
Version / Model: Foam ear tip 10 mm, ER1/ER2
Company Name: Interacoustics A/S
Labeler DUNS: 306308354
Distribution Status: In Commercial Distribution
Device Count in Pkg: 50
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: 7b66c86d-cefb-4b2d-8acb-d67034640f95

Device Description

Foam ear tip 10 mm, ER1/ER2

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	05711117244168	GS1
Primary	05711117230499	GS1

Premarket Submissions

Submission Number	Supplement Number
K930553	000