FDA.reportPublic FDA data

AED

Primary DI
00848657021463
Brand
AED
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
LO-50
Device description
50W LED Light Source
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00848657021463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657021463008486570214638486570214630848657021463

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
839138955
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817325025003iVisionMEDIMAX TECH INC.NTN2026-04-30
00851289007354FireflyFirefly GlobalNTN2025-07-18
00857556008642BR Surgical, LLCBR Surgical, LLCNTN2025-07-16
04547410513790FUJIFILMFUJIFILM CORPORATIONNTN2025-05-31
04580137732617MACHIDAMACHIDA ENDOSCOPE CO.,LTD.NTN2025-03-27
04953170458170OTV-S500 UPGRADE PACK STROBEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458231AIR MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458248MICROPHONE EXTENSION CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458255HDMI CABLEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
04953170458354THROAT MICROPHONEOLYMPUS MEDICAL SYSTEMS CORP.NTN2025-03-17
06970462546214Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
06970462546221Single-use Biliary Pancreaticobiliary ScopeShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2025-02-28
04250480100271NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100288NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100295NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100325NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100349NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100356NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480100363NASCHÖLLY FIBEROPTIC GmbHNTN2025-01-15
04250480101735NASCHÖLLY FIBEROPTIC GmbHNTN2024-12-03
04048551317488n.aKarl Storz GmbH & Co. KGNTN2024-11-29
04953170454141VISERA S VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NTN2024-11-14
00840183528522BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183528539BR Surgical, LLCBR Surgical, LLCNTN2024-10-25
00840183500474BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00857556008567BR Surgical, LLCBR Surgical, LLCNTN2024-07-23
00810024670260Dragonfly Pancreaticobiliary Scope and Instrument Channel CapsCENTERPOINT SYSTEMS LLCNTN2024-07-22
00840183500023BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
00840183500047BR Surgical, LLCBR Surgical, LLCNTN2024-07-22
06970462546207Image ProcessorShenzhen HugeMed Medical Technical Development Co., Ltd.NTN2024-06-11