pink putty 2 x 8 g

GUDID EDET035001

DETAX GmbH

Earmould impression material

• Primary Device ID: EDET035001
• NIH Device Record Key: 5d93e8cb-bcc0-4ea5-af5e-26c2ea47e001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pink putty 2 x 8 g
• Version Model Number: 03500
• 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	EDET035001 [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: 2023-07-10
• Device Publish Date: 2023-06-30

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• EDET045921 - VITA VIONIC® DENT RESIN A3 1000g: 2025-06-23
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• EDET045941 - VITA VIONIC® DENT RESIN B3 1000g: 2025-06-23