OTOVIEW

Basic Information

• Brand Name: OTOVIEW
• Primary DI: 00821925027183
• Version / Model: REX23-5211
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 4
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: 10aea502-a8c4-4546-9c11-dedcf348529a

Device Description

REPAIR EXCHANGE OTOVIEW SCOPE 2.4 MM 30 DEGREES

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWA	SET, AUDIOMETER CALIBRATION	Ear, Nose, Throat	874.1080	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44929	Otoscope, endoscopic	An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925027183	GS1

Premarket Submissions

Submission Number	Supplement Number
K934432	000