Big Easy® Piston

GUDID 00763000036638

PROSTHESIS 1156622 PLAT/TI .5X4.75M RT

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00763000036638
• NIH Device Record Key: 28657ad8-53f6-452a-9549-768ba8187135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Big Easy® Piston
• Version Model Number: 1156622
• 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
• 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: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.75 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000036638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002897

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

On-Brand Devices [Big Easy® Piston]

• 00763000036584: PROSTHESIS 1156604 PLAT/TI .5MMX4.75MM
• 00763000036577: PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM
• 00763000036560: PROSTHESIS 1156602 PLAT/TI .5MMX4.25MM
• 00763000036553: PROSTHESIS 1156601 PLAT/TI .5MMX4MM
• 00763000036645: PROSTHESIS 1156623 PLAT/TI .5X5MM RT
• 00763000036638: PROSTHESIS 1156622 PLAT/TI .5X4.75M RT
• 00763000036621: PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
• 00763000036614: PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
• 00763000036607: PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT
• 00763000036591: PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT