Extension module, 1 handle, ri-former®

Basic Information

• Brand Name: Extension module, 1 handle, ri-former®
• Primary DI: 04045396126879
• Version / Model: 300
• Catalog Number: 300
• Company Name: Rudolf Riester GmbH
• Labeler DUNS: 537208717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7e5cda92-7fb9-44ba-93a9-97c938ad6c65

Device Description

Diagnostic stations for diagnostic ENT instrument heads for non-invasive diagnosis.

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
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	886.1570	2

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	04045396126879	GS1

Premarket Submissions

Submission Number	Supplement Number
K950914	000