OTOPRONT

Basic Information

• Brand Name: OTOPRONT
• Primary DI: 04260154541002
• Version / Model: BASIC PLUS
• Company Name: Happersberger Otopront GmbH
• Labeler DUNS: 315858175
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-04
• Public Version: 1
• Public Version Date: 2023-07-12
• Public Version Status: New
• Public Device Record Key: 4d73160f-f4f3-4047-b2d6-89fb6fd49b37

Device Characteristics

• Single Use: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	874.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11585	ENT examination/treatment system	An assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suction/blowing apparatus, equipment drawers, and a mirror heater.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260154541002	GS1