Pack of 10 pcs. reusable ear specula Ø 3.0 mm,

Basic Information

• Brand Name: Pack of 10 pcs. reusable ear specula Ø 3.0 mm,
• Primary DI: 04045396011779
• Version / Model: 10834
• Catalog Number: 10834
• 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: 6b14b573-adae-4ee5-a065-c508090635f6

Device Description

With the Riester ear specula in combination with a Riester otoscope, the auditory canal is illuminated and examined.

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
33395	Ear speculum, reusable	A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04045396011779	GS1

Premarket Submissions

Submission Number	Supplement Number
K932503	000