FDA.reportPublic FDA data

CorPath Interventional Cockpit

Primary DI
00816280021013
Brand
CorPath Interventional Cockpit
Company
Corindus, Inc.
Model
101
Catalog number
101
Published
2016-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWXBarrier, Control Panel, X-Ray, Movable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWXBarrier, Control Panel, X-Ray, MovableRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816280021013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816280021013008162800210138162800210130816280021013

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding material, ionizingA radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas.

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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816280023192CorPath GRX Cassette Duo3193192022-08-08
00816280021037Powervision Imaging System1031032017-01-25
00816280021044Powervision Imaging System1041042017-01-25
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

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Primary DI, Brand, Company table
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00814907020555ScatPadCARDIO-MEDICAL PRODUCTS, INC.IWX2024-09-11
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