FotoTec® DLP.C 90800

GUDID E239908001

No.

Dreve Otoplastik GmbH

Earmould, custom-made

• Primary Device ID: E239908001
• NIH Device Record Key: 49000c32-6162-40f2-a08c-432b52e932a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FotoTec® DLP.C
• Version Model Number: 90800
• Catalog Number: 90800
• 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
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• Phone: +49230388070
• Email: otoplastik@dreve.de
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• 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	E239908001 [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: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [FotoTec® DLP.C]

• E239901001: No.
• E2399095011: No.
• E239908001: No.
• E239903001: No.