FDA.reportPublic FDA data

AED ENDOPRO® PRIMO SERIES CAMERA

Primary DI
00848657077088
Brand
AED ENDOPRO® PRIMO SERIES CAMERA
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
EP2050HD
Device description
AED ENDOPRO® PRIMO SERIES CAMERA
Published
2025-01-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWFCamera, Television, Endoscopic, Without Audio
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWFCamera, Television, Endoscopic, Without AudioGeneral, Plastic Surgery1
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657077088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657077088008486570770888486570770880848657077088

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848657078481AED8815SB2026-10-08
00848657078498AED8810SB2026-10-08
00848657078504AED1010122026-10-08
00848657078511AED10121-A2026-10-08
00848657078528AEDAED26173AD2026-10-08
00848657083805AED1010162026-10-08
00848657083904AED1010012026-10-08
00848657078467AED101021-A2026-10-05
00848657078474AED101011-A2026-10-05
00848657083782AED1012112026-10-05
00848657083812AED1013112026-10-05
00848657083843AED1010662026-10-05
00848657083874AED1010002026-10-05
00848657083898AED1010212026-10-05
00848657084956AED101013T2026-10-05
00848657084963AED101066-L2026-10-05
00848657084970AED101066-S2026-10-05
00848657087698AED1010152026-10-05
00848657078450AED5729A2026-07-22
00848657076609AEDU57402026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334050037BarcoBarco NVKQM2026-10-01
05415334050068BarcoBarco NVKQM2026-10-01
04251303302353CuratOREIZO GmbHKQM2026-09-28
04251303302377CuratOREIZO GmbHKQM2026-09-28
03700712438487Maquet OrchideMAQUET SASKQM2026-09-18
03700712438494Maquet OrchideMAQUET SASKQM2026-09-18
10197344213627MEDLINEMEDLINE INDUSTRIES, INC.KQM2026-07-20
00819761023117Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
00819761023124Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-25
04995047074885CuratOREIZO CORPORATIONKQM2026-06-24
00819761023063Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023087Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-05
00819761023094Optik ViewLINDEN GROUP CORPORATION, THEKQM2026-06-04
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
00840319757987Hayden MedicalHayden Medical, Inc.FWF2026-04-23
00840319758984Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00840319758991Hayden MedicalHayden Medical, Inc.FWF2026-04-22
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
08051887043286THD DIGITAL MINICAMTHD SPAFWF2025-02-20
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15