Fotoplast® Gel 44831

GUDID E239448311

No.

Dreve Otoplastik GmbH

Earmould, custom-made

• Primary Device ID: E239448311
• NIH Device Record Key: 5ce045ad-c7c4-4853-afa9-9af547e5f350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fotoplast® Gel
• Version Model Number: 44831
• Catalog Number: 44831
• Company DUNS: 315808340
• Company Name: Dreve Otoplastik 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49230388070
• Email: otoplastik@dreve.de

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239448311 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [Fotoplast® Gel]

• E239448211: No.
• E239448111: No.
• E239447911: No.
• E239446911: No.
• E239446511: No.
• E239446221: No.
• E239446121: No.
• E239448411: No.
• E239448311: No.