GUDID 00681490035248

PROSTHESIS 1156223 FLPL PLAT PISTON 4.5

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00681490035248
• NIH Device Record Key: a4ad0691-4cee-4336-88e3-f20b94cff4a6
• Commercial Distribution Discontinuation: 2018-12-20
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 1156223
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490035248 [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: 2019-02-18
• Device Publish Date: 2015-06-23

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