FDA.reportPublic FDA data

VorOtek O Scope

Primary DI
09348227001938
Brand
VorOtek O Scope
Company
VOROTEK PTY LTD
Model
VSOH-3D
Catalog number
VSOH-3D
Device description
VorOtek O Scope - HeadBand - 3D. 12mm Converged Binocular Optics & Fully Integrated LED Illumination with 3 dioptre Magnification. Adjustable IPD. Includes Power Pack, Charger & Carry Case.
Published
2023-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJHLoupe, Binocular, Low Power

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348227001938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348227001938093482270019389348227001938

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744332997
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348227002164VorOtek SpeculumsVPS-B50-LVPS-B50-L2023-09-08
09348227002171VorOtek SpeculumsVPS-B50-MVPS-B50-M2023-09-08
09348227002188VorOtek SpeculumsVPS-B50-SVPS-B50-S2023-09-08
09348227002195VorOtek SpeculumsVPS-B50-XLVPS-B50-XL2023-09-08
09348227002201VorOtek SpeculumsVPS-B50-XSVPS-B50-XS2023-09-08
09348227000016VorOtek O ScopeVSOS-2DVSOS-2D2023-08-09
09348227000023VorOtek O ScopeVSOH-2DVSOH-2D2023-08-09
09348227000092VorOtek L ScopeVSLH-2.5 LVSLH-2.5 L2023-08-09
09348227000108VorOtek L ScopeVSLH-2.5 MVSLH-2.5 M2023-08-09
09348227000160VorOtek M ScopeVSMSVSMS2023-08-09
09348227001181VorOtek X-Series HeadlightVLHH-DAVLHH-DA2023-08-09
09348227002089VorOtek O ScopeVSOS-3DVSOS-3D2023-08-09
09348227000153VorOtek M ScopeVSMHVSMH2023-08-08
09348227000290VorOtek LED HeadLightVLHH-DVLHH-D2023-08-08
09348227000139VorOtek L ScopeVSLS-2.5 MVSLS-2.5 M2023-07-24
09348227000122VorOtek L ScopeVSLS-2.5 LVSLS-2.5 L2023-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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