HARMONICA 11205

GUDID 08054187381140

Harmonica is a wired digital video-otoscope that integrates a high-definition camera with chip-on-tip and a LED system.

INVENTIS SRL

Otoscope, direct

• Primary Device ID: 08054187381140
• NIH Device Record Key: 40db5c64-c5b3-4224-9c82-a67ca069694c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARMONICA
• Version Model Number: HARMONICA
• Catalog Number: 11205
• Company DUNS: 338454995
• Company Name: INVENTIS SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054187381140 [Primary]

FDA Product Code

• ERA: Otoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

Devices Manufactured by INVENTIS SRL

• 08054187380815 - Synapsys VHIT: 2025-01-16 Video Head Impulse Test device
• 08054187380822 - Synapsys VHIT: 2025-01-16 Video Head Impulse Test device
• 08054187380983 - VNG: 2024-10-09 Video nystagmograph
• 08054187380990 - VNG: 2024-10-09 Video nystagmograph
• 08054187381003 - VNG: 2024-10-09 Video nystagmograph
• 08054187381010 - VNG: 2024-10-09 Video nystagmograph
• 08054187381027 - VNG: 2024-10-09 Video nystagmograph
• 08054187381034 - VNG: 2024-10-09 Video nystagmograph