Bojrab

GUDID 00763000036508

PROSTHESIS 0385 BOJRAB UNIV POLYCEL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000036508
• NIH Device Record Key: fac767c4-7054-4baa-8e92-468fe089331f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bojrab
• Version Model Number: 0385
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000036508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823912

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: 2021-11-15
• Device Publish Date: 2021-11-07

On-Brand Devices [Bojrab]

• 00681490023788: PROSTHESIS 0507 BOJRAB UNIV 9.0
• 00681490023764: PROSTHESIS 0506 BOJRAB UNIVERSAL 7MM
• 00681490017572: PROSTHESIS 0308 BOJRAB UNIV H/A OFFSET
• 00681490017565: PROSTHESIS 0306 BOJRAB UNIV HA 7MM
• 00721902817427: PROSTHESIS 0385 BOJRAB UNIV POLYCEL
• 00763000036508: PROSTHESIS 0385 BOJRAB UNIV POLYCEL
• 00763000034375: PROSTHESIS 0507 BOJRAB UNIV 9.0
• 00763000034368: PROSTHESIS 0506 BOJRAB UNIVERSAL 7MM
• 00763000034221: PROSTHESIS 0308 BOJRAB UNIV H/A OFFSET
• 00763000034214: PROSTHESIS 0306 BOJRAB UNIV HA 7MM