Lesinski

GUDID 00763000034313

PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL

MEDTRONIC XOMED, INC.

Ossicular prosthesis, partial
Primary Device ID00763000034313
NIH Device Record Key1ea0c109-9574-4407-a60a-0bf9a6a22c3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLesinski
Version Model Number0428
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 Perscriptionfalse
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000034313 [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 Date2023-12-18
Device Publish Date2023-12-08

On-Brand Devices [Lesinski]

00681490024259PROSTHESIS 0532 LESINSKI FLEX H/A TOTAL
00681490024235PROSTHESIS 0531 LESINSKI FLEX H/A PART
00681490024198PROSTHESIS 0530 LESINSKI FLEX H/A TOTAL
00681490023436PROSTHESIS 0437 LESINSKI MOD LOOP 4.25MM
00681490023429PROSTHESIS 0436 LESINSKI FLPL/PLATINUM
00681490023412PROSTHESIS 0435 LESINSKI MOD LOOP 4.5MM
00681490023337PROSTHESIS 0429 PISTON .6X4.75 PLAT/FLPL
00681490023320PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL
00681490023313PROSTHESIS 0427 PISTON .6X4.25 PLT/FLPL
00681490017664PROSTHESIS 0320 STAPEDOTOMY REVISION
00763000034320PROSTHESIS 0429 PISTON .6X4.75 PLAT/FLPL
00763000034313PROSTHESIS 0428 PISTON .6X4.5 PLAT/FLPL
00763000033286PROSTHESIS 0427 PISTON .6X4.25 PLT/FLPL

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