FDA.reportPublic FDA data

High CRI LED Light Source

Primary DI
00851321006109
Brand
High CRI LED Light Source
Company
VITALCOR, INC
Model
847400
Catalog number
847400
Device description
High CRI LED Light Source
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NTNLed light source

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851321006109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851321006109008513210061098513210061090851321006109

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)874-8358info@vitalcor.com

Regulatory Flags#

DUNS number
020942546
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851321006000Coronary Artery Perfusion Cannula3158043158042016-09-16
00851321006017Coronary Artery Perfusion Cannula3158053158052016-09-16
00851321006024Coronary Artery Perfusion Cannula3158063158062016-09-16
00851321006031Coronary Artery Perfusion Cannula3158073158072016-09-16
00851321006048Coronary Artery Perfusion Cannula3158083158082016-09-16
00851321006055Coronary Artery Perfusion Cannula4158044158042016-09-16
00851321006062Coronary Artery Perfusion Cannula4158064158062016-09-16
00851321006079Coronary Artery Perfusion Cannula4158054158052016-09-16
00851321006086Coronary Artery Perfusion Cannula4158074158072016-09-16
00851321006093Coronary Artery Perfusion Cannula4158084158082016-09-16
10851321006007Coronary Artery Perfusion Cannula3158043158042016-09-16
10851321006014Coronary Artery Perfusion Cannula3158053158052016-09-16
10851321006021Coronary Artery Perfusion Cannula3158063158062016-09-16
10851321006038Coronary Artery Perfusion Cannula3158073158072016-09-16
10851321006045Coronary Artery Perfusion Cannula3158083158082016-09-16
10851321006052Coronary Artery Perfusion Cannula4158044158042016-09-16
10851321006069Coronary Artery Perfusion Cannula4158064158062016-09-16
10851321006076Coronary Artery Perfusion Cannula4158054158052016-09-16
10851321006083Coronary Artery Perfusion Cannula4158074158072016-09-16
10851321006090Coronary Artery Perfusion Cannula4158084158082016-09-16

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