SULTAN VENT TUBE 127 MM ID FLUOROPLASTIC

GUDID 00821925019706

Gyrus Acmi, Inc.

Tympanostomy tube

• Primary Device ID: 00821925019706
• NIH Device Record Key: 22530a8e-53ac-44f4-8a08-77f2b566fd22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SULTAN VENT TUBE 127 MM ID FLUOROPLASTIC
• Version Model Number: 145230-ENT
• 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

Customer Support Contacts

• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
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• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
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• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx
• Phone: 18002623540
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925019706 [Package]; Contains: 00821925038974; Package: [6 Units]; In Commercial Distribution
GS1	00821925038974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992222

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: 2015-10-24