FDA.reportPublic FDA data

ZEISS Optical Insert - Demo

Primary DI
04064495038012
Brand
ZEISS Optical Insert - Demo
Company
Carl Zeiss Vision International GmbH
Model
39000033083
Catalog number
39000033083
Device description
ZEISS Optical Insert - DEMO
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
04064495038012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064495038012040644950380124064495038012

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

Contacts#

Phone, Email table
PhoneEmail
+1(423)598-2680jahmal.cannon@zeiss.com

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
04064495039408ZEISS Optical Insert- Reader39000033082390000330822024-01-19
04064495039415ZEISS Optical Inserts39000032753390000327532023-12-20
04064495038029ZEISS Optical InsertsSpecial Single Vision390000319602023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00054917321697Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321703Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321840Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917321857Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339777Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917339791Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340247Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340261Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340278Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340292Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917340308Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345914Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345938Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917345945Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00054917347673Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821163Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821170Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821187Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821194Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821200Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821217Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821224Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821231Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821248Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821255Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821262Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821279Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821286Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478821293Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25
00648478825475Bollé BrandsBOLLE BRANDS (FRANCE)HQG2025-09-25