Roberson

GUDID 00885074006659

PROSTHESIS 1133065 ROBERSON STPS .9X4.25

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial

• Primary Device ID: 00885074006659
• NIH Device Record Key: 43664cd8-0c49-4e3b-8a52-f0e5e6e6edcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Roberson
• Version Model Number: 1133065
• 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

Device Dimensions

• Length: 4.25 Millimeter
• Length: 4.25 Millimeter
• Length: 4.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885074006659 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-25

On-Brand Devices [Roberson]

• 00721902837968: PROSTHESIS 1133064 ROBERSON STAPES 1X4.5
• 00721902837951: PROSTHESIS 1133063 ROBERSON STAPES 1X4
• 00721902837944: PROSTHESIS 1133062 ROBERSN STAPES .9X4.5
• 00721902837937: PROSTHESIS 1133061 ROBERSON STAPES .9X4
• 00885074006666: PROSTHESIS 1133066 ROBERSN STAPES 1X4.25
• 00885074006659: PROSTHESIS 1133065 ROBERSON STPS .9X4.25