addition spectra budget packing automix 1

GUDID EDET032021

DETAX GmbH

Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material Earmould impression material

• Primary Device ID: EDET032021
• NIH Device Record Key: 177407a7-e493-4fbb-8585-44ca0ea608d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: addition spectra budget packing automix 1
• Version Model Number: 03202
• Company DUNS: 343947949
• Company Name: DETAX 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDET032021 [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: 2023-07-11
• Device Publish Date: 2023-07-03

Devices Manufactured by DETAX GmbH

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• EDET034481 - Flexible tube for minimix cannulas, 20 cm: 2024-02-20
• EDET032451 - bulk box mix.cann.optima lila 2500pcs: 2023-12-29
• EDET044151 - Primeprint Splint ST 1000g: 2023-11-02
• EDET044161 - Primeprint Splint SF 1000g: 2023-11-02
• EDET044411 - FREEPRINT splintmaster flex 1000g: 2023-11-02
• EDET044421 - FREEPRINT splintmaster taff 1000g: 2023-11-02
• EDET021831 - mixing cannulas blue 25 pcs.: 2023-07-12