Systems Configuration

GUDID 00815948020061

PENUMBRA, INC.

Thrombectomy suction catheter
Primary Device ID00815948020061
NIH Device Record Key12b24dae-99d5-4640-ae59-602a4fff8976
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystems Configuration
Version Model NumberACE603DVELSYS-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 Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948020061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2018-01-26

Devices Manufactured by PENUMBRA, INC.

00810169722039 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 1cm
00810169722046 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 2cm
00810169722053 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 3cm
00810169722060 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 1mm x 5cm
00810169722077 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 2mm x 2cm
00810169722084 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 2mm x 4cm
00810169722091 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 2mm x 6cm
00810169722107 - swiftMATCH Coil, Extra Soft2026-02-03 swiftMATCH Coil, Extra Soft, 3mm x 4cm

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