FDA.reportPublic FDA data

MASUNAGA since 1905

Primary DI
04582644462254
Brand
MASUNAGA since 1905
Company
MASUNAGA OPTICAL MFG.CO.,LTD.
Model
GMS-817 39 MBK 48
Published
2022-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04582644462254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582644462254045826444622544582644462254

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693743585
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582647307606MASUNAGA since 1905GLIDE 32 AT-S/AT-G 472026-04-13
04582647307613MASUNAGA since 1905Chord S 11 AT-Gold 522026-04-13
04582647307620MASUNAGA since 1905Chord S 22 AT-Silver 522026-04-13
04582647307637MASUNAGA since 1905Chord S 39 Black 522026-04-13
04582647307644MASUNAGA since 1905Chord S 41 Gold 522026-04-13
04582647307651MASUNAGA since 1905Chord S 52 Silver 522026-04-13
04582647307675MASUNAGA since 1905Tobi 31 SG-AT-G/AT-S 552026-04-13
04582647307682KOOKIKOOKI 575 1 BLUE BRUSHED MAT 512026-04-13
04582647307699KOOKIKOOKI 575 2 BROWN-D.GREY MAT 512026-04-13
04582647307705KOOKIKOOKI 575 3 D.GRY-BLACK SHINY-MAT 512026-04-13
04582647307712KOOKIKOOKI 575 4 ANT.GOLD SHINY-MAT 512026-04-13
04582647307330MASUNAGA since 1905MIES II 41 Gold/Black 532026-02-24
04582647307347MASUNAGA since 1905MIES II 59 Black/Silver 532026-02-24
04582647307354MASUNAGA since 1905GMS-124 48 GREEN 472026-02-24
04582647307361MASUNAGA since 1905GMS-125 45 BLUE 472026-02-24
04582647307378MASUNAGA since 1905GMS-125 53 BR 472026-02-24
04582647307385MASUNAGA since 1905108 34 A-GRY 522026-02-24
04582647307392MASUNAGA since 1905108 45 A-BLUE 522026-02-24
04582647307408MASUNAGA since 1905108 34 U-GRY 522026-02-24
04582647307415MASUNAGA since 1905108 45 U-BLUE 522026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30