FDA.reportPublic FDA data

PROGREAT

Primary DI
04987350738141
Brand
PROGREAT
Company
TERUMO CORPORATION
Model
MC*PC2013ZRC
Catalog number
MC*PC2013ZRC
Device description
PROGREAT Microcatheter System
Published
2021-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, intravascular, diagnostic
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
54987350738146PackageGS15In Commercial Distribution
04987350738141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735073814654987350738146
04987350738141049873507381414987350738141

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Centimeter
Lumen/Inner Diameter0.49Millimeter
Outer Diameter0.67Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
690543319
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09
04987350383099HEARTRAIL40-6371GC-U6IL350A2016-09-09
04987350383112HEARTRAIL40-6372GC-U6IL3G0N2016-09-09
04987350383136HEARTRAIL40-6373GC-U6IL400N2016-09-09
04987350383150HEARTRAIL40-6374GC-U6IL400A2016-09-09
04987350383174HEARTRAIL40-6375GC-U6IL450N2016-09-09
04987350383198HEARTRAIL40-6376GC-U6IL450A2016-09-09
04987350383235HEARTRAIL40-6380GC-U6IR100N2016-09-09
04987350383259HEARTRAIL40-6381GC-U6IR150N2016-09-09
04987350383273HEARTRAIL40-6382GC-U6IR200N2016-09-09
04987350423795HEARTRAIL40-6383GC-U6IR100A2016-09-09
04987350423818HEARTRAIL40-6385GC-U6IR200A2016-09-09
04987350423832HEARTRAIL40-6377GC-U6IL3G0A2016-09-09
04987350423856HEARTRAIL40-6384GC-U6IR150A2016-09-09
04987350423870HEARTRAIL40-6311GC-U6TG400N2016-09-09
04987350703163FINECROSS35-1430NC*F863A2016-09-09
04987350703187FINECROSS35-1450NC*F865A2016-09-09
04987350709165NAVICROSSNC35651WS*NA350G3H2016-09-09
04987350709189NAVICROSSNC35901WS*NA35093H2016-09-09
04987350709202NAVICROSSNC35131WS*NA350N3H2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399672PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399702PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399719PhenomTM 27 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399733PhenomTM Plus CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00847536041707PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2019-04-22