FDA.reportPublic FDA data

Ngenuity

Primary DI
00380650001139
Brand
Ngenuity
Company
Alcon Laboratories, Inc.
Model
00380650001139
Device description
Microsurgical Camera
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FWJCAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWJCamera, Cine, Microsurgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380650001139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650001139003806500011393806500011390380650001139

GMDN Terms#

Term, Definition table
TermDefinition
Microscope video cameraAn electro-optical device (e.g., with an image sensor chip) designed to convert visual images from a light microscope into digital video (digital conversion) for subsequent electronic display/storage. The device may include an appropriate adaptor for microscope attachment and may include audio recording capabilities. It may be attached to laboratory and/or surgical microscopes to document laboratory examinations and surgical procedures, respectively.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008018525
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657530892LEGION80657530892026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260751840041I.C.LERCHERI.C.LERCHER-Solutions GmbHFWJ2026-05-13
04260751841338I.C.LERCHERI.C.LERCHER-Solutions GmbHFWJ2025-04-01
00380650003997NGENUITYAlcon Laboratories, Inc.FWJ2024-06-19
04260751840812I.C.LERCHERI.C.LERCHER-Solutions GmbHFWJ2023-01-16
00380657530915NgenuityAlcon Laboratories, Inc.FWJ2022-09-28