Biopor® AB 28117

GUDID E239281171

No.

Dreve Otoplastik GmbH

Earmould, custom-made

• Primary Device ID: E239281171
• NIH Device Record Key: f1e0a581-f79d-4055-8412-b95d285054d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopor® AB
• Version Model Number: 28117
• Catalog Number: 28117
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239281171 [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: 2024-05-07
• Device Publish Date: 2024-04-29

On-Brand Devices [Biopor® AB ]

• E239282001: No.
• E23928411: No.
• E2392821: No.
• E239288021: No.
• E23928493M1: No.
• E239284931: No.
• E239284921: No.
• E23928472M1: No.
• E239284721: No.
• E23928462M1: No.
• E239284621: No.
• E23928452M1: No.
• E239284521: No.
• E23928443M1: No.
• E239284431: No.
• E23928442M1: No.
• E239284421: No.
• E23928434M1: No.
• E239284341: No.
• E23928433M1: No.
• E239284331: No.
• E23928432M1: No.
• E239284321: No.
• E23928423M1: No.
• E239284231: No.
• E23928422M1: No.
• E239284221: No.
• E23928416M1: No.
• E239284161: No.
• E23928415M1: No.
• E239284151: No.
• E23928414M1: No.
• E239284141: No.
• E23928413M1: No.
• E239284131: No.
• E23928412M1: No.
• E239284121M1: No.
• E2392841211: No.
• E23928401M1: No.
• E239284011: No.
• E239284001: No.
• E239284121: No.
• E23928400M1: No.
• E239283911: No.
• E23928361M1: No.
• E239283611: No.
• E23928351M1: No.
• E239283511: No.
• E23928331M1: No.
• E239283311: No.