Flex H/A

GUDID 00763000913526

PROSTHESIS 0524 FLEX H/A PARTIAL 3MM HD

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial
Primary Device ID00763000913526
NIH Device Record Keyf7ea4dc6-f212-4b3c-99e9-c4cfc1e90665
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex H/A
Version Model Number0524
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100763000913526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

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

On-Brand Devices [Flex H/A]

00763000913601PROSTHESIS 0580 INCUS NECROSIS MED
00763000913595PROSTHESIS 0570 FLEX H/A OFFSET 4X5
00763000913564PROSTHESIS 0541 FLEX H/A MALLEUS PARTIAL
00763000913557PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL
00763000913533PROSTHESIS 0525 CAUSSE FLEX H/A OFF TOTL
00763000913526PROSTHESIS 0524 FLEX H/A PARTIAL 3MM HD
00763000913519PROSTHESIS 0523 FLEX H/A TOTAL 3MM HD

Trademark Results [Flex H/A]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEX H/A
FLEX H/A
74312208 1772896 Live/Registered
MEDTRONIC XOMED, INC.
1992-09-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.