Microgel

GUDID 20763000870359

VENT TUBE 1082201 5PK PAPA TYPE 1.14

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000870359
• NIH Device Record Key: e4fa27a2-e554-4df9-a53d-fe0cd94ddb4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microgel
• Version Model Number: 1082201
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000870355 [Primary]
GS1	20763000870359 [Package]; Contains: 00763000870355; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151067

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-01
• Device Publish Date: 2025-06-23

On-Brand Devices [Microgel]

• 20763000870779: VENT TUBE 25501 MICROGEL 5PK ARMSTG 1.14
• 20763000870762: VENT TUBE 25441 MICROGEL 5PK PAPA 1.02
• 20763000870359: VENT TUBE 1082201 5PK PAPA TYPE 1.14