Precise II 743

GUDID E2397431

No.

Dreve Otoplastik GmbH

Earmould impression kit

• Primary Device ID: E2397431
• NIH Device Record Key: b9dc5279-0d31-4a98-bffc-29d2be821581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise II
• Version Model Number: 743
• Catalog Number: 743
• 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

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	E2397431 [Primary]

FDA Product Code

• LDG: Kit, earmold, impression

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: 2022-12-13
• Device Publish Date: 2022-12-05

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• E23904171501 - Pre-bent tubing: 2025-01-21 No.
• E239042501 - Pre-bent tubing: 2025-01-21 No.
• E23911311 - Silicone tubing: 2025-01-21 No.
• E23920211 - Silicone tubing: 2025-01-21 No.