ri-scope® F.O. tongue blade holder LED 3.5 V

Basic Information

• Brand Name: ri-scope® F.O. tongue blade holder LED 3.5 V
• Primary DI: 04045396141322
• Version / Model: 10574
• Catalog Number: 10574
• 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: d7f83c54-d58e-4cc9-9130-a84c0fd097a6

Device Description

The blade holder described in these Operating Instructions is produced for examination of the oral cavity and pharynx in combination with commercial wooden and plastic blades.

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
ERA	Otoscope	Ear, Nose, Throat	874.4770	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12276	Fixed examination/treatment room light	A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04045396141322	GS1

Premarket Submissions

Submission Number	Supplement Number
K950913	000