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
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
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24
00380657502806Alcon, Infiniti, MicroSmooth, ABS80657502802016-09-24
00380657517190Alcon, Infiniti, Intrepid, ABS80657517192016-09-24
00380657520886Alcon, Infiniti, Intrepid80657520882016-09-24
00300650193108OPTI-FREE EXPRESSOPTI-FREE EXPRESS 10ml2016-09-24
00300650193207OPTI-FREE EXPRESSOPTI-FREE EXPRESS 20ml2016-09-24
00380657402601Alcon80657402602016-09-24
00380652268899ACRYSOF, IQ RESTORSND1T3SND1T3U1302017-02-24
00380658552008Clareon TruPlusREYWT8REYWT8.2502026-05-14
00380658552015Clareon TruPlusREYWT8REYWT8.2552026-05-14
00380658552022Clareon TruPlusREYWT8REYWT8.2602026-05-14
00380658552039Clareon TruPlusREYWT8REYWT8.2652026-05-14
00380658552046Clareon TruPlusREYWT8REYWT8.2702026-05-14
00380658552053Clareon TruPlusREYWT8REYWT8.2752026-05-14

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