Mini otoscope 3000

Basic Information

• Brand Name: Mini otoscope 3000
• Primary DI: 04053755125494
• Version / Model: 10-143-00
• Catalog Number: 10-143-00
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-26
• Public Version: 1
• Public Version Date: 2022-10-04
• Public Version Status: New
• Public Device Record Key: 103f5287-6d8d-4027-83a4-4aaba00fcca2

Device Description

with battery handle 2.5 V batteries 4 multi use ear specula

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
EQH	SOURCE, CARRIER, FIBEROPTIC LIGHT	Ear, Nose, Throat	874.4350	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	04053755125494	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]