GUDID 00681490033350

PROSTHESIS 1112085 H/A TOTAL 90 OFF RND

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00681490033350
• NIH Device Record Key: 721be631-85a7-4faf-89a4-77ddb10742eb
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1112085
• 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: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490033350 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-19

Devices Manufactured by MEDTRONIC XOMED, INC.

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• 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
• 00763000578039 - N/A: 2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL
• 00763000578046 - N/A: 2024-09-24 SPLINT 1528120 25PK EXTERNAL NASAL MED
• 00763000578053 - N/A: 2024-09-24 SPLINT 1528121 5PK EXTERNAL NASAL MEDIUM
• 00763000578060 - N/A: 2024-09-24 SPLINT 1528137 25PK EXTERNAL NASAL LARGE