FDA.reportPublic FDA data

Powervision Imaging System

Primary DI
00816280021044
Brand
Powervision Imaging System
Company
Corindus, Inc.
Model
104
Catalog number
104
Published
2017-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816280021044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816280021044008162800210448162800210440816280021044

GMDN Terms#

Term, Definition table
TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-653-3335customer.service@corindus.com
+1-800-888-7436XX@XX.XX
+1-800-888-7436contact@siemens-healthineers.com

Regulatory Flags#

DUNS number
781746586
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816280023192CorPath GRX Cassette Duo3193192022-08-08
00816280021013CorPath Interventional Cockpit1011012016-11-16
00816280021037Powervision Imaging System1031032017-01-25
00816280021051CorPath Imaging System1051052017-01-25
00816280021068CorPath Imaging System1061062017-01-25
00816280023017CorPath GRX Control Console3013012017-01-20
00816280023024CorPath GRX Extended Reach Arm3023022017-01-20
00816280023031CorPath GRX Robotic Drive3033032017-01-20
00816280023055CorPath GRX Cassette3053052017-01-20
00816280023079CorPath GRX Drive Gear3073072017-01-20
00816280023093CorPath GRX Drape, Robotic Drive and Arm3093092017-01-20
00816280023116CorPath GRX Drape, Control Console3113112017-01-20
00816280023123CorPath GRX Extended Reach Arm3123122018-04-05
00816280021020Powervision Imaging System1021022017-01-25
00816280022010CorPath 200 Control Console160-00043160-000432016-09-24
00816280022027CorPath 200 Articulated Arm160-00807160-008072016-09-24
00816280022034CorPath 200 Robotic Drive160-00050160-000502016-09-24
00816280022041CorPath 200 Cassette160-00173-NC160-00173-NC2016-09-24
00816280022072CorPath 200 POGO Pin Caps160-00876160-008762016-09-24
00816280022096CorPath 200 Control Console Drape160-00981160-009812016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28