OTOPRONT

GUDID 04260154540012

Happersberger Otopront GmbH

ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system ENT examination/treatment system

• Primary Device ID: 04260154540012
• NIH Device Record Key: 76e08994-7f9f-4f3f-8c2e-1d7e0ef33423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOPRONT
• Version Model Number: SMART
• Company DUNS: 315858175
• Company Name: Happersberger Otopront GmbH
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260154540012 [Primary]

FDA Product Code

• ETF: Unit, Examining/Treatment, Ent

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: 2023-07-12
• Device Publish Date: 2023-07-04

On-Brand Devices [OTOPRONT]

• 04260154548407: SIT 4 PLUS ER
• 04260154548308: SIT 4 PLUS E
• 04260154548209: SIT 4 PLUS
• 04260154548117: SIT 4
• 04260154548100: SIT 4
• 04260154546731: OTOLUX-LED
• 04260154546663: PES Pilot HDpro
• 04260154546656: PES Pilot HDpro
• 04260154541606: BASIC PLUS
• 04260154541309: BASIC PLUS
• 04260154541026: BASIC PLUS
• 04260154541019: BASIC PLUS
• 04260154541002: BASIC PLUS
• 04260154540012: SMART