OTOPRONT

GUDID 04260154546663

Happersberger Otopront GmbH

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 04260154546663
• NIH Device Record Key: b5f61c62-dd16-4ede-b92f-c77e14ca7d11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTOPRONT
• Version Model Number: PES Pilot HDpro
• 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	04260154546663 [Primary]

FDA Product Code

• FWC: Camera, Television, Surgical, With Audio

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