econom® XL 3.5 V, C-handle,

Basic Information

• Brand Name: econom® XL 3.5 V, C-handle,
• Primary DI: 04045396130739
• Version / Model: 2054-202
• Catalog Number: 2054-202
• Company Name: Rudolf Riester GmbH
• Labeler DUNS: 537208717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-28
• Public Version: 1
• Public Version Date: 2021-02-05
• Public Version Status: New
• Public Device Record Key: 7b2b936a-631d-4f20-a8e1-4d6a14d5f95f

Device Description

The nasal speculum is produced for illumination and therefore examination of the inside of the nose. The blade holder is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades. The laryngeal mirrors are produced for mirroring or examination of the oral cavity and pharynx in combination with the Riester bent-arm illuminator. The Riester otoscope is produced for illumination and examination of the auditory canal in combination with Riester ear specula The Riester ophthalmoscope is produced for the examination of the eye and the eyeground.

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: 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
EPY	Speculum, Ent	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45085	ENT diagnostic set	A collection of battery-powered devices intended to be used by a physician to perform an ear/nose/throat (ENT) clinical examination on a patient. The devices are typically enclosed in a dedicated case and may include an ophthalmoscope, an otoscope, a pharyngoscope, a dedicated interchangeable handle that contains the batteries, which may be rechargeable and common to all the examination devices, different attachments (e.g., ear specula, mirrors, tongue depressors), spare parts (e.g., light bulbs), and may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04045396130739	GS1

Premarket Submissions

Submission Number	Supplement Number
K925754	000