FDA.reportPublic FDA data

AMNOTEC

Primary DI
04250942120601
Brand
AMNOTEC
Company
AMNOTEC International Medical GmbH
Model
71-146-30 NIR C-US
Catalog number
71-146-30 NIR C-US
Device description
VEQTRON ICG/NIR Cold Light Cable, Ø 4.5 mm, L. 300 cm, Autoclavable
Published
2023-06-05
Public version status
Update
Distribution status
Not 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
04250942120601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250942120601042509421206014250942120601

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
Dry Heat Sterilization

Regulatory Flags#

DUNS number
342569940
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250942101402AMNOTEC71-068-05 NIR71-068-05 NIR2023-06-01
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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