FotoTec® DLP.A 24955

GUDID E239249551

No.

Dreve Otoplastik GmbH

Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made Earmould, custom-made

• Primary Device ID: E239249551
• NIH Device Record Key: dd504d4a-a971-46d1-9b84-6f8fd2bcb3c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FotoTec® DLP.A
• Version Model Number: 24955
• Catalog Number: 24955
• 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
• 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

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239249551 [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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [FotoTec® DLP.A]

• E239249501: No.
• E239249101: No.
• E239249001: No.
• E239248201: No.
• E239248101: No.
• E239247201: No.
• E239247101: No.
• E239247001: No.
• E239246901: No.
• E239246801: No.
• E23924670OTI1: No.
• E239246601: No.
• E239246501: No.
• E239246401: No.
• E239246301: No.
• E239246201: No.
• E239246001: No.
• E239245501: No.
• E239245001: No.
• E23924390GN1: No.
• E23924380GN1: No.
• E23924370GN1: No.
• E23924360GN1: No.
• E23924350GN1: No.
• E239243001: No.
• E239242601: No.
• E239242001: No.
• E23924170SO1: No.
• E23924160SO1: No.
• E23924150SO1: No.
• E23924130SO1: No.
• E23924120SO1: No.
• E23924110SO1: No.
• E239241001: No.
• E239240001: No.
• E239244001: No.
• E239249551: No.