Sheehy HA/C Polycel® T.O.P.

GUDID 00763000034849

PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000034849
• NIH Device Record Key: 18e1ddbd-f362-40f4-8da2-eee54072a69f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sheehy HA/C Polycel® T.O.P.
• Version Model Number: 1112363
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810707

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

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: 2024-05-20
• Device Publish Date: 2024-05-12

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000003036 - NIM Vital™: 2024-11-15 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0
• 00763000842543 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS
• 00763000842550 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
• 00763000842567 - Bipolar Stimulating Probe: 2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
• 00763000891862 - ENT NIM Electrode: 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS
• 00763000891879 - ENT NIM Electrode: 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS
• 00763000580483 - ENT NIM Vital: 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS
• 00763000578022 - N/A: 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL