GUDID 00681490035330

PROSTHESIS 1156258 FLPL PLT PSTN .6X4.75

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total 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.

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• 20763000282992 - Shah: 2024-04-29 VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
• 00763000849573 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE
• 00763000849580 - PTEYE Parathyroid Detection System: 2024-04-12 CONSOLE PTEYE-RF REFURBISHED
• 00763000882389 - NIM: 2024-02-12 EMG TUBE 8229306 NIM STD 6MM ROHS
• 00763000882396 - NIM: 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS
• 00763000882402 - NIM: 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS
• 00763000882419 - NIM: 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS