GUDID 20681490069292

STYLETS 3118515 10PK IRRIGATION

MEDTRONIC XOMED, INC.

Surgical instrument/endoscope cleaning adaptor

• Primary Device ID: 20681490069292
• NIH Device Record Key: d6ea6070-970e-4f25-b1bb-a61c389269b5
• Commercial Distribution Discontinuation: 2018-10-24
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 3118515
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490069298 [Primary]
GS1	20681490069292 [Package]; Contains: 00681490069298; Package: PK [10 Units]; Discontinued: 2018-10-24; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791407

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-05-02

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00199150023868 - N/A: 2026-02-24 PROBE 8225101 5PK PRASS STD PROT HANDLE
• 00199150023875 - N/A: 2026-02-24 PROBE 8225110 10PK PRASS STD
• 00199150023882 - N/A: 2026-02-24 PROBE 8225103 5PK PRASS SLIM PROT HANDLE
• 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