ARMSTRONG V TYPE VENT TUBE STRAIGHT, BLUE 1.14MM ID 4.5MM LENGTH FLUO

GUDID 00821925020221

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925020221
• NIH Device Record Key: c266774a-f332-4413-a43c-76151eeb6299
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARMSTRONG V TYPE VENT TUBE STRAIGHT, BLUE 1.14MM ID 4.5MM LENGTH FLUO
• Version Model Number: 70140398
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• 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	00821925020221 [Package]; Contains: 00821925032705; Package: [6 Units]; In Commercial Distribution
GS1	00821925032705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000801

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

On-Brand Devices [ARMSTRONG V TYPE VENT TUBE STRAIGHT, BLUE 1.14MM ID 4.5MM LENGTH FLUO]

• 00821925020238: 70140399
• 00821925020221: 70140398