RICHARDS T-TUBE 1.14 MM ID 12 MM LENGTH SILICONE

GUDID 00821925019584

Gyrus Acmi, Inc.

Tympanostomy tube

• Primary Device ID: 00821925019584
• NIH Device Record Key: 9f80ad57-b575-4216-af44-70dfc482d707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RICHARDS T-TUBE 1.14 MM ID 12 MM LENGTH SILICONE
• Version Model Number: 240071
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925019584 [Package]; Contains: 00821925031999; Package: [6 Units]; In Commercial Distribution
GS1	00821925031999 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932166

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-11

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