Bailey Pappas

GUDID 00681490035835

PROSTHESIS 1156468 CUP PISTON .6X4 SST

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial Ossicular prosthesis, partial
Primary Device ID00681490035835
NIH Device Record Key21612228-0d4e-4d14-997f-d33c2de7908a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBailey Pappas
Version Model Number1156468
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

Device Dimensions

Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter
Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490035835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-22

On-Brand Devices [Bailey Pappas]

00681490035859PROSTHESIS 1156470 CUP PISTON .6X4.5 SST
00681490035842PROSTHESIS 1156469 CUP PISTN .6X4.25 SST
00681490035835PROSTHESIS 1156468 CUP PISTON .6X4 SST
00681490035828PROSTHESIS 1156454 SST BUCKET .4X4.50
00681490035811PROSTHESIS 1156453 SST BUCKET .4X4.25
00681490035804PROSTHESIS 1156452 SST BUCKET .4X4.0

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