20763000870373

GUDID 20763000870373

VENT TUBE 1084401 5PK GROMMET 1.27

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000870373
• NIH Device Record Key: 8ab419ac-bcc1-4a1b-b4fd-b9029c30e860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20763000870373
• Version Model Number: 1084401
• 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
• 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
• 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
• 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	00763000870379 [Primary]
GS1	20763000870373 [Package]; Contains: 00763000870379; 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

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000548797 - Hydrodebrider: 2026-02-23 HYDRODEBRIDER 1914001 STD HANDPIECE ROHS
• 00763000548803 - Hydrodebrider: 2026-02-23 HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS
• 20763000888910 - Merocel: 2026-02-23 PACKING 400151 100PK MICRO SPHERES 4MM
• 20763000888927 - Merocel: 2026-02-23 PACKING 400152 100PK MICRO SPHERES 5MM
• 00763000956028 - Tubing Set: 2026-02-23 IRRIG SET 3318604E IPC SUCTION W/RC
• 00643169547087 - NIM®: 2025-09-22 MAINFRAME 8253402 NEURO 3.0 INTL EL ROHS
• 00763000745080 - NuVent™: 2025-08-25 INFLATOR KIT 18INFKIT BALLOON
• 00763000831479 - NIM™: 2025-08-19 PROBE NIMDTP35 ENDO 35CM 1MM BALL TIP