GUDID 00681490035316

PROSTHESIS 1156256 FLPL PLT PSTN .6X4.25

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total
Primary Device ID00681490035316
NIH Device Record Key6be39be1-b7b5-405e-8266-84501d200428
Commercial Distribution Discontinuation2018-06-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number1156256
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490035316 [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 Number4
Public Version Date2018-07-06
Device Publish Date2015-06-23

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