LMI ARTERIAL EMBOLECTOMY CATHETER

GUDID B3804FEMB1000

LUCAS MEDICAL INC

Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter Thrombectomy balloon catheter
Primary Device IDB3804FEMB1000
NIH Device Record Key4d1ef713-95a2-49c8-9674-0fe456b08147
Commercial Distribution StatusIn Commercial Distribution
Brand NameLMI ARTERIAL EMBOLECTOMY CATHETER
Version Model Number4FEMB100
Company DUNS878198993
Company NameLUCAS MEDICAL INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3804FEMB1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


[B3804FEMB1000]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

On-Brand Devices [LMI ARTERIAL EMBOLECTOMY CATHETER]

B380NL7FEMB80T0NL7FEMB80T
B380NL7FEMB800NL7FEMB80
B380NL7FEMB40T0NL7FEMB40T
B380NL7FEMB400NL7FEMB40
B380NL7EMB80T0NL7EMB80T
B380NL7EMB800NL7EMB80
B380NL7EMB40T0NL7EMB40T
B380NL7EMB400NL7EMB40
B380NL6FEMB80T0NL6FEMB80T
B380NL6FEMB800NL6FEMB80
B380NL6FEMB40T0NL6FEMB40T
B380NL6FEMB400NL6FEMB40
B380NL6EMB80T0NL6EMB80T
B380NL6EMB800NL6EMB80
B380NL6EMB40T0NL6EMB40T
B380NL6EMB400NL6EMB40
B380NL5FEMB80T0NL5FEMB80T
B380NL5FEMB800NL5FEMB80
B380NL5FEMB40T0NL5FEMB40T
B380NL5FEMB400NL5FEMB40
B380NL5EMB80T0NL5EMB80T
B380NL5EMB800NL5EMB80
B380NL5EMB40T0NL5EMB40T
B380NL5EMB400NL5EMB40
B380NL4FEMB80T0NL4FEMB80T
B380NL4FEMB800NL4FEMB80
B380NL4FEMB40T0NL4FEMB40T
B380NL4FEMB400NL4FEMB40
B380NL4FEMB1000NL4FEMB100
B380NL4EMB80T0NL4EMB80T
B380NL4EMB800NL4EMB80
B380NL4EMB40T0NL4EMB40T
B380NL4EMB400NL4EMB40
B380NL4EMB1000NL4EMB100
B380NL3FEMB80T0NL3FEMB80T
B380NL3FEMB800NL3FEMB80
B380NL3FEMB40T0NL3FEMB40T
B380NL3FEMB400NL3FEMB40
B380NL3EMB80T0NL3EMB80T
B380NL3EMB800NL3EMB80
B380NL3EMB40T0NL3EMB40T
B380NL3EMB400NL3EMB40
B380NL2FEMB60T0NL2FEMB60T
B380NL2FEMB600NL2FEMB60
B380NL2FEMB40T0NL2FEMB40T
B380NL2FEMB400NL2FEMB40
B380NL2EMB60T0NL2EMB60T
B380NL2EMB600NL2EMB60
B380NL2EMB40T0NL2EMB40T
B380NL2EMB400NL2EMB40

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