FDA.reportPublic FDA data

Visionflex

Primary DI
09352527000775
Brand
Visionflex
Company
VISIONFLEX PTY. LTD.
Model
VFGEISCAM1.04
Device description
GEIS Camera (General Examination Imaging System) is a handheld device that can capture medical grade quality images and video in Full HD 1080p resolution at the touch of a button.
Published
2020-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWBCamera, Television, Surgical, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWBCamera, Television, Surgical, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09352527000782PackageGS11In Commercial Distribution
09352527000799PackageGS11In Commercial Distribution
09352527000775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352527000782093525270007829352527000782
09352527000799093525270007999352527000799
09352527000775093525270007759352527000775

GMDN Terms#

Term, Definition table
TermDefinition
Surgical camera lensAn optical element of a surgical camera designed to change the degree of convergence or divergence of transmitted light to enable modification of viewed images (e.g., magnification, wide angle). It is made of glass and is available in a variety of dimensions. This is a non-sterilizable, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
752219480
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09352527001185Visionflex VFPROEX23.032021-02-19
09352527001192Visionflex VFPROEX24.032021-02-19
09352527001161Visionflex VFPROEX21.032021-02-19
09352527001307Visionflex VFPROEX23.032021-02-19
09352527001314Visionflex VFPROEX24.032021-02-19
09352527000553VisionflexVFPROEX21.022020-08-17
09352527000560Visionflex VFPROEX22.022020-08-17
09352527000577VisionflexVFPROEX23.022020-08-17
09352527000584Visionflex VFPROEX24.022020-08-17
09352527000591VisionflexVFPROEX25.022020-08-17
09352527000607Visionflex VFPROEX26.022020-08-17
09352527000614VisionflexVFPROEX21.032020-08-17
09352527000669Visionflex VFPROEXMOBILE1.012020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195174123508LGLG Electronics Inc.FWB2025-07-24
00195174123515LGLG Electronics Inc.FWB2025-07-24
00195174113875LGLG Electronics Inc.FWB2025-01-08
00195174112779LGLG Electronics Inc.FWB2024-12-13
00195174081310LGLG Electronics Inc.FWB2023-11-30
00195174073216LGLG Electronics Inc.FWB2023-10-23
00195174073155LGLG Electronics Inc.FWB2023-09-12
00195174073179LGLG Electronics Inc.FWB2023-09-12
00195174073186LGLG Electronics Inc.FWB2023-09-12
06933741405183HisenseQingdao Hisense Medical Equipment Co., Ltd.FWB2023-09-11
00195174067154ARTHREXLG Electronics Inc.FWB2023-06-19
00195174053850LGLG Electronics Inc.FWB2023-05-10
00195174061435LGLG Electronics Inc.FWB2023-03-08
00859151005286MTSMEDICAPTURE, INC.FWB2023-02-21
07613327592146"32"" 4K OLED Surgical Display"STRYKER CORPORATIONFWB2022-11-18
00195174047316LGLG Electronics Inc.FWB2022-09-26
00195174027059LGLG Electronics Inc.FWB2022-06-07
00195174033753LGLG Electronics Inc.FWB2022-06-07
00700621719533StrykerBarco, Inc.FWB2022-03-02
00700621719557StrykerBarco, Inc.FWB2022-03-02
00700621719564StrykerBarco, Inc.FWB2022-03-02
00700621719571StrykerBarco, Inc.FWB2022-03-02
00700621719588StrykerBarco, Inc.FWB2022-03-02
00195174025604LGLG Electronics Inc.FWB2021-09-07
00195174004524LGLG Electronics Inc.FWB2020-10-15
00195174006764LGLG Electronics Inc.FWB2020-10-15
00719192609198LGLG Electronics Inc.FWB2020-06-08
00719192609600LGLG Electronics Inc.FWB2020-06-08
00719192617605LGLG Electronics Inc.FWB2020-06-08
00719192624214LGLG Electronics Inc.FWB2020-06-08