Lesinski

GUDID 00763000034313

PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00763000034313
• NIH Device Record Key: 1ea0c109-9574-4407-a60a-0bf9a6a22c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lesinski
• Version Model Number: 0428
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000034313 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-18
• Device Publish Date: 2023-12-08

On-Brand Devices [Lesinski]

• 00681490024259: PROSTHESIS 0532 LESINSKI FLEX H/A TOTAL
• 00681490024235: PROSTHESIS 0531 LESINSKI FLEX H/A PART
• 00681490024198: PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL
• 00681490023436: PROSTHESIS 0437 LESINSKI MOD LOOP 4.25MM
• 00681490023429: PROSTHESIS 0436 LESINSKI FLPL/PLATINUM
• 00681490023412: PROSTHESIS 0435 LESINSKI MOD LOOP 4.5MM
• 00681490023337: PROSTHESIS 0429 PISTON .6X4.75 PLAT/FLPL
• 00681490023320: PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL
• 00681490023313: PROSTHESIS 0427 PISTON .6X4.25 PLT/FLPL
• 00681490017664: PROSTHESIS 0320 STAPEDOTOMY REVISION
• 00763000034320: PROSTHESIS 0429 PISTON .6X4.75 PLAT/FLPL
• 00763000034313: PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL
• 00763000033286: PROSTHESIS 0427 PISTON .6X4.25 PLT/FLPL