Brackmann

GUDID 00681490035453

PROSTHESIS 1156303 BRACKMANN TOTAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00681490035453
• NIH Device Record Key: f5a3c811-fd67-4897-89a0-d0fcb2cefbec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brackmann
• Version Model Number: 1156303
• 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	00681490035453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822367

FDA Product Code

• LBN: REPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE

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: 2015-07-01

On-Brand Devices [Brackmann]

• 00681490035453: PROSTHESIS 1156303 BRACKMANN TOTAL
• 00681490033657: PROSTHESIS 1112305 BRACKMANN PARTIAL