FDA.reportPublic FDA data

Fielmann

Primary DI
04066209058934
Brand
Fielmann
Company
Fielmann Group AG
Model
MF 061 RN GIGI_28843
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04066209058934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04066209058934040662090589344066209058934

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Regulatory Flags#

DUNS number
312583602
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04066209006799FielmannBD 404 MOD FLEX CL_213272026-07-14
04066209008311FielmannBD 457 FLEX CL_211112026-07-14
04066209008885FielmannBD 480 FA_221992026-07-14
04066209045118FielmannBD 550 CL_251812026-07-14
04066209054578FielmannBD 464 MOD CL_281822026-07-14
04066209026032FielmannMI 029 CL_211372026-07-08
04066209033016FielmannCOMFORT 117 CL_227042026-07-08
04066209033184FielmannJIL 018 CL_227602026-07-08
04066209040083FielmannTITANIUM 199 FLEX CL_241612026-07-08
04066209044883FielmannMF 057 RN_251652026-07-08
04066209046917FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209046924FielmannCOMFORT 129 FLEX CL_254232026-07-08
04066209047051FielmannJIL 009 CL_254272026-07-08
04066209049178FielmannTITANIUM 206 CL UWE_257452026-07-08
04066209051140FielmannJIL 033 FLEX CL_276092026-07-08
04066209051201FielmannJIL 032 FLEX CL_276182026-07-08
04066209052475FielmannBE 032 FA_279342026-07-08
04066209052673FielmannABC 080 FLEX CL KIM_279762026-07-08
04066209052697FielmannABC 080 FLEX CL KIM_279752026-07-08
04066209052932FielmannABC 079 FLEX FA AMANDA_279852026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736087377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088091ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088138ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098311ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098359ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098397ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098434ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002734ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002772ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002819ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002857ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504026020ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504027140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736092616ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092654ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092692ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092739ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097833ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097871ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097918ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097956ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000617ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000693ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000730ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025702ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025740ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02