Donldsn

GUDID 20763000281643

VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube Tympanostomy tube

• Primary Device ID: 20763000281643
• NIH Device Record Key: b21c98d5-c756-4ed9-99a2-46460b259450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Donldsn
• Version Model Number: 1015101
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000281649 [Primary]
GS1	20763000281643 [Package]; Contains: 00763000281649; 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000033385 - HA/C Polycel® Brackmann Total: 2024-05-20 PROSTHESIS 1112303 BRACKMANN H/AC TOTAL
• 00763000034832 - Sheehy HA/C Polycel® P.O.P.: 2024-05-20 PROSTHESIS 1112362 SHEEHY POP H/A POLYCL
• 00763000034849 - Sheehy HA/C Polycel® T.O.P.: 2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL
• 00763000036591 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT
• 00763000036607 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT
• 00763000036614 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
• 00763000036621 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
• 00763000036638 - Big Easy® Piston: 2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT