FDA.reportPublic FDA data

VS3-ETV

Primary DI
18130400103403
Brand
VS3-ETV
Company
VISIONSENSE LTD.
Model
153-0003
Catalog number
153-0003
Device description
VS3 Endoscope 4mm, ETV, 0°, Wide FOV
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWGEndoscope, Neurological
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWGEndoscope, NeurologicalNeurology2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153548000VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEMVisionsense, Ltd.2016-02-22HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18130400103403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1813040010340318130400103403

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

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