GUDID 00681490024822

PROSTHESIS 0570 FLEX H/A OFFSET 4X5

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00681490024822
• NIH Device Record Key: d35cb048-923b-43cd-8f1f-76dfe7da2b55
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 0570
• 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	00681490024822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K885201

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: 2015-06-25

Devices Manufactured by MEDTRONIC XOMED, INC.

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• 00763000831479 - NIM™: 2025-08-19 PROBE NIMDTP35 ENDO 35CM 1MM BALL TIP
• 20763000831480 - NIM™: 2025-08-19 PROBE 8225490X 3PK INCREMENTING 1MM TIP
• 20763000831497 - NIM™: 2025-08-19 PROBE 8225825X 3PK INCREMT STD PRASS TIP
• 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