COMBILIGHT C10 otoscope with plastic head, 2.5 V

Basic Information

• Brand Name: COMBILIGHT C10 otoscope with plastic head, 2.5 V
• Primary DI: 04030155000194
• Version / Model: 01.12110.001
• Catalog Number: 01.12110.001
• Company Name: Kirchner & Wilhelm GmbH + Co KG
• Labeler DUNS: 315480269
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-30
• Public Version: 1
• Public Version Date: 2023-09-07
• Public Version Status: New
• Public Device Record Key: 965f01a5-da2d-453d-b932-10266ee453ba

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: 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
12849	Otoscope, direct	An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04030155000194	GS1