FDA.reportPublic FDA data

Penumbra System

Primary DI
00815948020955
Brand
Penumbra System
Company
PENUMBRA, INC.
Model
5MAXJET7-B
Device description
5MAXJET7-B
Published
2019-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NRYCatheter, Thrombus Retriever

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRYCatheter, Thrombus RetrieverCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948020955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948020955008159480209558159480209550815948020955

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M4244002C03060Penumbra Coil 4004002C03062016-07-30
M4244002C03100Penumbra Coil 4004002C03102016-07-30
M4244002C04080Penumbra Coil 4004002C04082016-07-30
M4244002C04120Penumbra Coil 4004002C04122016-07-30
M4244002C05060Penumbra Coil 4004002C05062016-07-30
M4244002C05100Penumbra Coil 4004002C05102016-07-30
M4244002C06100Penumbra Coil 4004002C06102016-07-30
M4244002C06150Penumbra Coil 4004002C06152016-07-30
M4244002C07100Penumbra Coil 4004002C07102016-07-30
M4244002C07150Penumbra Coil 4004002C07152016-07-30
M4244002C07200Penumbra Coil 4004002C07202016-07-30
M4244002C08150Penumbra Coil 4004002C08152016-07-30
M4244002C08200Penumbra Coil 4004002C08202016-07-30
M4244002C08300Penumbra Coil 4004002C08302016-07-30
M4244002C09150Penumbra Coil 4004002C09152016-07-30
M4244002C09250Penumbra Coil 4004002C09252016-07-30
M4244002C09350Penumbra Coil 4004002C09352016-07-30
M4244002C10200Penumbra Coil 4004002C10202016-07-30
M4244002C10300Penumbra Coil 4004002C10302016-07-30
M4244002C10400Penumbra Coil 4004002C10402016-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857545008295Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008301Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008318Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008325Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00857545008332Lynx Aspiration Catheter SystemQ'APEL MEDICAL LLCNRY2026-05-29
00763000974077Riptide™Micro Therapeutics, Inc.NRY2026-03-30
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVesalioNRY2026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVesalioNRY2026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVesalioNRY2026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVesalioNRY2026-03-26
00850014025182APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025199APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025205APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
00850014025212APRO 45 Swift CatheterAlembic, LLCNRY2026-03-25
07290015107341Tigertriever 25 Revascularization DeviceRAPID MEDICAL LTDNRY2026-03-16
00763000950750Riptide™ Aspiration PumpMicro Therapeutics, Inc.NRY2026-03-09
05391530910231Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
05391530910248Esperance pHLO Aspiration SystemPHENOX LIMITEDNRY2026-02-10
00763000974091Riptide™Micro Therapeutics, Inc.NRY2025-12-13
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
00812212030788Zoom 4S CatheterIMPERATIVE CARE, INC.NRY2025-11-24
07290015107402Tigertriever 17 Ultra Revascularization DeviceRAPID MEDICAL LTDNRY2025-11-17
10886704088097CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088103CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088110CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704088141CEREGLIDECerenovus, Inc.NRY2025-10-13
10886704086437CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086451CEREGLIDECerenovus, Inc.NRY2025-09-26
10886704086475CEREGLIDECerenovus, Inc.NRY2025-09-26