ZEISS Optical Inserts

Primary DI
04064495038029
Brand
ZEISS Optical Inserts
Company
Carl Zeiss Vision International GmbH
Model
Special Single Vision
Catalog number
39000031960
Device description
ZEISS Optical Inserts
Published
2023-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQGLens, Spectacle, Non-Custom (Prescription)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQGLens, Spectacle, Non-Custom (Prescription)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064495038029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064495038029040644950380294064495038029

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectacle lens, custom-madeAn ophthalmic lens made of glass or plastic that is manufactured in accordance with a specific patient prescription (custom-made) and intended to be worn in front of the eyes to correct the refractive errors of that patient's eyesight, e.g., refractive ametropia (myopia, hyperopia and astigmatism), and possibly to protect the eyes against radiation or mechanical hazards; it has no additional specialized features. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344934760
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
04064495038012ZEISS Optical Insert - Demo39000033083390000330832024-02-02
04064495039408ZEISS Optical Insert- Reader39000033082390000330822024-01-19
04064495039415ZEISS Optical Inserts39000032753390000327532023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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