GUDID 00681490035330

PROSTHESIS 1156258 FLPL PLT PSTN .6X4.75

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00681490035330
• NIH Device Record Key: a69cf869-11d7-4b2b-b473-2fa088c47a30
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 1156258
• 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

Device Dimensions

• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter
• Length: 4.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490035330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872112

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-23

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000309480 - Causse/Polycel: 2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL
• 20763000870359 - Microgel: 2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14
• 20763000870366 - Sheehy: 2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27
• 20763000870373 - 20763000870373: 2025-07-01 VENT TUBE 1084401 5PK GROMMET 1.27
• 20763000870380 - Reuter: 2025-07-01 VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL
• 20763000870403 - Sheehy: 2025-07-01 VENT TUBE 1013301 5PK BUTTON 1.27 FLPL
• 20763000870410 - Donaldson: 2025-07-01 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL
• 20763000870427 - Shepard: 2025-07-01 VENT TUBE 1016101 5PK GROMMET 1.14 FLPL