STRAIGHT VENT TUBE PACIFIC 114MM ID FLUOROPLASTIC PC COATED

GUDID 00821925039162

Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear while creating an avenue passage for air pressure equalization on either side of the drum.

Gyrus Acmi, Inc.

Tympanostomy tube

• Primary Device ID: 00821925039162
• NIH Device Record Key: 905aa832-29d6-4e08-96bf-ae66f1cb95fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAIGHT VENT TUBE PACIFIC 114MM ID FLUOROPLASTIC PC COATED
• Version Model Number: 70141041
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 2
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925024953 [Package]; Package: [60 Units]; In Commercial Distribution
GS1	00821925039162 [Primary]
GS1	00821925040915 [Unit of Use]

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: 2015-10-24

On-Brand Devices [STRAIGHT VENT TUBE PACIFIC 114MM ID FLUOROPLASTIC PC COATED]

• 00821925039162: Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear whi
• 00821925024946: Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear whi
• 00821925024939: Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear whi