Brackmann / Polycel®

GUDID 00763000035389

PROSTHESIS 1156303 BRACKMANN TOTAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total

• Primary Device ID: 00763000035389
• NIH Device Record Key: 755afff9-4b86-4fb4-a971-6a022fa7464f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brackmann / Polycel®
• 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
• 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

• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000035389 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-15
• Device Publish Date: 2021-11-07

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00643169547087 - NIM®: 2025-09-22 MAINFRAME 8253402 NEURO 3.0 INTL EL ROHS
• 00763000745080 - NuVent™: 2025-08-25 INFLATOR KIT 18INFKIT BALLOON
• 00763000831479 - NIM™: 2025-08-19 PROBE NIMDTP35 ENDO 35CM 1MM BALL TIP
• 20763000831480 - NIM™: 2025-08-19 PROBE 8225490X 3PK INCREMENTING 1MM TIP
• 20763000831497 - NIM™: 2025-08-19 PROBE 8225825X 3PK INCREMT STD PRASS TIP
• 00763000309480 - Causse/Polycel: 2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL
• 20763000870359 - Microgel: 2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14
• 20763000870366 - Sheehy: 2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27