otosil ES-1.1

Basic Information

• Brand Name: otosil ES-1.1
• Primary DI: EPRCA0032900
• Version / Model: Shore 60 / 8 double cartridges of 2 x 24 ml - white opaque
• Catalog Number: A0032900
• Company Name: pro3dure medical GmbH
• Labeler DUNS: 312947842
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-15
• Public Version: 1
• Public Version Date: 2022-09-23
• Public Version Status: New
• Public Device Record Key: 151619b4-68b7-4ced-86f4-b30a8d044241

Device Description

ES-1.1 / 60 Shore white opaque 8 double cartridges with 48 ml each

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ESD	Hearing Aid, Air Conduction	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41228	Earmould, custom-made	A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EPRCA0032900	HIBCC

Customer Contacts

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