Mansfield Smith

GUDID 00681490024976

PROSTHESIS 0595 SMITH FLEX HA STRUT 2.0

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00681490024976
• NIH Device Record Key: 2828d713-175b-4ff6-9d68-b59ee2949b08
• Commercial Distribution Discontinuation: 2018-06-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Mansfield Smith
• Version Model Number: 0595
• 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: 2 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490024976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904239

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-09

On-Brand Devices [Mansfield Smith]

• 00681490024983: PROSTHESIS 0596 SMITH FLEX HA STRUT 2.25
• 00681490024976: PROSTHESIS 0595 SMITH FLEX HA STRUT 2.0