FDA.reportPublic FDA data

AMNOTEC

Primary DI
04250942101402
Brand
AMNOTEC
Company
AMNOTEC International Medical GmbH
Model
71-068-05 NIR
Catalog number
71-068-05 NIR
Device description
VEQTRON ICG/NIR 4K UHD Endoscopic Fluorescence Imaging System, 4 CMOS, Camera Control Unit
Published
2023-06-01
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
GCJLaparoscope, General & Plastic Surgery
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
IZISystem, X-Ray, AngiographicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250942101402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250942101402042509421014024250942101402

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342569940
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250942104526AMNOTEC72-405-00 NIR72-405-00 NIR2023-11-13
04250942104533AMNOTEC72-405-30 NIR72-405-30 NIR2023-11-13
04250942104540AMNOTEC72-410-00 NIR72-410-00 NIR2023-11-13
04250942104557AMNOTEC72-410-30 NIR72-410-30 NIR2023-11-13
04051423017522AMNOTEC72-405-00-US72-405-00-US2023-08-18
04051423017539AMNOTEC72-405-30-US72-405-30-US2023-08-18
04051423024520AMNOTEC72-410-00-US72-410-00-US2023-08-18
04051423024537AMNOTEC72-410-30-US72-410-30-US2023-08-18
06973031299924AMNOTEC71-182-30 NIR71-182-30 NIR2023-08-18
04250942120854AMNOTEC71-705-52 NIR TT71-705-52 NIR TT2023-06-16
04250942120861AMNOTEC71-705-4671-705-462023-06-16
04250942104519AMNOTEC71-182-30 NIR71-182-30 NIR2023-06-05
04250942120564AMNOTEC72-405-00-US72-405-00-US2023-06-05
04250942120571AMNOTEC72-405-30-US72-405-30-US2023-06-05
04250942120588AMNOTEC72-410-00-US72-410-00-US2023-06-05
04250942120595AMNOTEC72-410-30-US72-410-30-US2023-06-05
04250942120601AMNOTEC71-146-30 NIR C-US71-146-30 NIR C-US2023-06-05
04056634016593AMNOTEC71-705-4671-705-462023-08-18
04056634063269AMNOTEC71-705-52 NIR TT71-705-52 NIR TT2023-08-18
06973031299795AMNOTEC71-146-30 NIR C-US71-146-30 NIR C-US2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506044366ELMEDELMED INCORPORATEDGCJ2026-06-09
00812231033906PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033913PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231033920PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034095PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
00812231034101PixaSANTA BARBARA IMAGING SYSTEMS, INC.GCJ2026-06-08
04717480900336Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900343Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900350Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900367Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900398Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900404Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900763Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900770Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900787Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
04717480900800Inno-PortTAIWAN SURGICAL CORPORATIONGCJ2026-06-08
E496C05HPDH0Handle for pneumodissection HookAB MEDICAGCJ2026-06-08
E496C05IDCH20ST1Hook insert and tube for pneumodissection D=5,0mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C05IDCH33ST1Hook insert and tube for pneumodissection D=5,0mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH20ST1Hook insert and tube for pneumodissection D=3,5mm Lg=20cm, sterile single useAB MEDICAGCJ2026-06-08
E496C35IDCH33ST1Hook insert and tube for pneumodissection D=3,5mm Lg=33cm, sterile single useAB MEDICAGCJ2026-06-08
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28