FDA.reportPublic FDA data

NGENUITY

Primary DI
00380650003997
Brand
NGENUITY
Company
Alcon Laboratories, Inc.
Model
00380650003997
Catalog number
8065000399
Device description
Microsurgical Camera
Published
2024-06-19
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
00380650003997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380650003997003806500039973806500039970380650003997

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.

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
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

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
04260751840812I.C.LERCHERI.C.LERCHER-Solutions GmbHFWJ2023-01-16
00380650001139NgenuityAlcon Laboratories, Inc.FWJ2022-09-28
00380657530915NgenuityAlcon Laboratories, Inc.FWJ2022-09-28