FDA.report

AED Solar 4500 50-Watt LED Light Source

Primary DI
00848657086974
Brand
AED Solar 4500 50-Watt LED Light Source
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
5700K
Catalog number
5700K
Device description
The device is designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It consists of an individual light head with more than one light source includes light-emitting diodes (LEDs) and a mechanism to adjust the focus.
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NTNLed Light Source

Product Code Classifications

CodeDeviceSpecialtyClass
NTNLed Light SourceGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848657086974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657086974008486570869748486570869740848657086974

GMDN Terms

TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods

Method

Contacts

PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags

DUNS number
839138955
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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