Sonopal® hard Lacquer Al M111300

GUDID E239M1113001

No.

Innovation MediTech GmbH

Earmould, custom-made

• Primary Device ID: E239M1113001
• NIH Device Record Key: 3369ba2d-35ba-41b1-beb3-5650b744851f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonopal® hard Lacquer Al
• Version Model Number: M111300
• Catalog Number: M111300
• Company DUNS: 313785693
• Company Name: Innovation MediTech 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: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@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
• 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	E239M1113001 [Primary]

FDA Product Code

• ESD: Hearing aid, air conduction

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: 2020-09-29
• Device Publish Date: 2020-09-21

Devices Manufactured by Innovation MediTech GmbH

• E239M1113001 - Sonopal® hard Lacquer Al: 2020-09-29No.
• E239M1113001 - Sonopal® hard Lacquer Al: 2020-09-29 No.
• E239M1113031 - Sonopal® hard Lacquer Al: 2020-09-29 No.
• E239M1113041 - Sonopal® hard Lacquer Al: 2020-09-29 No.
• E239M1113091 - Sonopal® hard Lacquer Al: 2020-09-29 No.
• E239M1115041 - Sonopal® soft Lacquer E: 2020-09-29 No.
• E239M1115051 - Sonopal® soft Lacquer E: 2020-09-29 No.
• E239M1115071 - Sonopal® soft Lacquer E: 2020-09-29 No.
• E239M700101 - VITA ENAMIC GLAZE: 2018-07-06 Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20