FDA.reportPublic FDA data

AED Solar 2010 Portable LED Light Source

Primary DI
00848657086677
Brand
AED Solar 2010 Portable LED Light Source
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
Solar 2010
Catalog number
Solar 2010
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. This device is portableand is 5 Watt powered.
Published
2020-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00848657086677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657086677008486570866778486570866770848657086677

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00848657078368AEDAED UH8012026-04-23
00848657078276AEDAED 33310UL-R2026-04-13
00848657078283AEDAED 33310UL2026-04-13
00848657078290AEDAED 33321A-R2026-04-13
00848657078306AEDAED 33321A2026-04-13
00848657078313AEDAED 33310FG-R2026-04-13
00848657078320AEDAED 33310FG2026-04-13
00848657078337AEDAED 33310R-R2026-04-13
00848657078344AEDAED 33310R2026-04-13
00848657078351AEDAED 34321SL2026-04-13
00848657078269AEDJZM15922026-03-02
00848657078238AED8830BL2026-02-24
00848657078245AED8830CL2026-02-24
00848657078252AED8830FL2026-02-24
00848657078214AED501.50BS2026-02-18
00848657078221AED501.51BS2026-02-18
00848657023122AEDAED11275FE2026-01-23
00848657023139AEDAED27071TJ2026-01-23
00848657068956AED2717462026-01-23
00848657069236AEDAED27071-92026-01-23

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04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
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