Brackmann/Polycel

GUDID 00763000913687

PROSTHESIS 1156303 BRACKMANN TOTAL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total
Primary Device ID00763000913687
NIH Device Record Key0d3f69c0-e7e5-47c0-9b90-cbbb64b1ebf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrackmann/Polycel
Version Model Number1156303
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000913687 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBNREPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLENE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-01
Device Publish Date2025-06-23

Devices Manufactured by MEDTRONIC XOMED, INC.

00763000309480 - Causse/Polycel2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL
20763000870359 - Microgel2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14
20763000870366 - Sheehy2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27
20763000870373 - 207630008703732025-07-01 VENT TUBE 1084401 5PK GROMMET 1.27
20763000870380 - Reuter2025-07-01 VENT TUBE 1010201 5PK BOBBIN 1.14 FLPL
20763000870403 - Sheehy2025-07-01 VENT TUBE 1013301 5PK BUTTON 1.27 FLPL
20763000870410 - Donaldson2025-07-01 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL
20763000870427 - Shepard2025-07-01 VENT TUBE 1016101 5PK GROMMET 1.14 FLPL

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