DURAVENT

GUDID 00821925032439

Gyrus Acmi, Inc.

Tympanostomy tube

• Primary Device ID: 00821925032439
• NIH Device Record Key: 4dc64a2b-ecfc-4da6-89ea-08b9e44f49e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DURAVENT
• Version Model Number: 245775
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 60
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925018143 [Primary]
GS1	00821925032439 [Unit of Use]

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

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