Penumbra System

GUDID 00815948023215

ACE 72, 125 cm, no CE

PENUMBRA, INC.

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter
Primary Device ID00815948023215
NIH Device Record Key3afcac90-e446-446e-a559-27c414bcacff
Commercial Distribution StatusIn Commercial Distribution
Brand NamePenumbra System
Version Model Number5MAXJET7BL125-A
Company DUNS191077671
Company NamePENUMBRA, 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 Datefalse
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
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]
GS100815948023215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever
NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


[00815948023215]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [Penumbra System]

00814548019956PS MAX RC3MAX, 160 cm
00814548019949PS MAX RC3MAX KIT
00814548019932PS MAX RC3MAX, 160 cm
008145480199185MAXJET7KIT-A
008145480199015MAXJET7-A
008145480198955MAXJET7L127-A
008145480198885MAXJET7L125-A
008145480198715MAXJET7L120-A
008145480198645MAXJET7L115-A
00814548017952Artemis Pump MAX Canister
00814548017853PSR3D-A
008145480178393d Revascularization Device
008145480175325MAXACE068KIT-B
008145480175255MAXACE068-B
008145480175185MAXACE068L127-B
008145480175015MAXACE068L120-B
008145480174955MAXACE068L125-B
008145480174885MAXACE068L115-B
008145480174335MAXACE132KIT-A
008145480174265MAXACE132-A
008145480174195MAXACE127-A
008145480174025MAXACE125-A
00814548016771PSC054KIT
008145480167573MAXCKIT
008145480167404MAXCKIT
008145480165975MAXACE068KIT-A
008145480165805MAXACE068-A
008145480165735MAXACE068L127-A
008145480165665MAXACE068L125-A
008145480165595MAXACE068L120-A
008145480165425MAXACE068L115-A
008145480164815MAXACE064KIT-A
00814548016207RC ACE 64, 132cm, noCE
00814548016191RC ACE 64, 127cm, noCE
00814548016184RC ACE 64, 125cm, noCE
00814548016177RC ACE 64, 120cm, noCE
00814548016160RC ACE 64, 115cm, noCE
00814548016139SmtCoil Handle
00814548013626RC5MAX ACE, 115cm
00814548013343Indigo Pump Max Supplies
008145480132754MAX DDC, 130cm
00814548012803RC5MAX ACE, 132cm
00814548012797RC5MAX ACE, 127cm
00814548012780RC5MAX ACE, 125cm
00814548012773Pump Max 110V
00814548012766PS MAX RC5MAX 127cm, CE
00814548012759PS MAX RC5MAX 125cm
00814548012742PS Max RC5MAX 132cm, CE
00814548012698Pump Max 220V
008145480126745MAX DDC, 125cm

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