GUDID 00681490034739

PROSTHESIS 1133650 CUP STAPES .8X4.25 SS

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial
Primary Device ID00681490034739
NIH Device Record Key03168cf6-89e3-4118-93ea-388a27021ada
Commercial Distribution Discontinuation2018-10-24
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number1133650
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Length4.25 Millimeter
Length4.25 Millimeter
Length4.25 Millimeter
Length4.25 Millimeter
Length4.25 Millimeter
Length4.25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490034739 [Primary]

FDA Product Code

ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-18
Device Publish Date2015-06-23

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

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