FDA.reportPublic FDA data

VS3-IR

Primary DI
10813040013186
Brand
VS3-IR
Company
VISIONSENSE LTD.
Model
153-0052RFB
Catalog number
153-0052RFB
Device description
VS3 Iridium Endoscope-IR 5.5mm, Long, 30°, Standard FOV - Refurbished
Published
2020-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GWGEndoscope, Neurological
HRXArthroscope
OWNConfocal Optical Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GWGEndoscope, NeurologicalNeurology2
HRXArthroscopeOrthopedic2
OWNConfocal Optical ImagingGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152204000VS3-IR systemVisionsense, Ltd.2015-10-28OWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813040013186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081304001318610813040013186

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;Hydrogen Peroxide

Regulatory Flags#

DUNS number
532199478
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
18130400103342VS3560-6462560-64622016-09-23
18130400103571VS3 Bifurcated Light Cable for MMSVS3-MMS560-63182016-09-23
18130400103588VS3 Iridium - Y Laser Light Cable for FluorescenceVS3-IR560-65442016-09-23
10884521815926VS3-IR175-00512024-11-11
10884521816695VS3-IR153-00542024-11-11
10884521816701VS3-IR153-00552024-11-11
10884521816718VS3-IR153-00742024-11-11
10884521816725VS3-IR153-00752024-11-11
10884521821187VS3-NE443-00012024-11-11
10884521844681VS3 Iridium175-0012RFB2024-11-11
10884521844698VS3 Iridium465-0011RFB2024-11-11
10884521834644VS3-IR460-0011460-00112022-05-09
10813040013858VS3 Iridium 153-0053153-00532019-08-07
10813040013704VS3-IR175-0051175-00512020-06-11
10813040013711VS3-IR175-0012175-00122020-06-11
10813040013728VS3-IR465-0011465-00112020-06-11
10884521842489VS3-NE443-0001443-00012023-03-13
10813040013636VS3 Iridium 153-0073153-00732019-08-07
10884521833173VS3-NE443-0001443-00012022-05-10
10884521834651VS3-IR465-0011465-00112022-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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