FDA.report

MASUNAGA since 1905

Primary DI
04580786582014
Brand
MASUNAGA since 1905
Company
MASUNAGA OPTICAL MFG.CO.,LTD.
Model
030 23 A-BR TORTOISE 51
Published
2022-03-03
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

Related Records

Product Codes

CodeName
HQZFrame, Spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04580786582014PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
693743585
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 DIBrandModelCatalogPublished
04582647307286KOOKIKOOKI 574 1 L.BROWN-BLUE 542025-12-22
04582647307293KOOKIKOOKI 574 2 D.GRY-BLACK 542025-12-22
04582647307309KOOKIKOOKI 574 3 BLUE-GRY 542025-12-22
04582647307316KOOKIKOOKI 574 4 BLACK-SILVER 542025-12-22
04582647307255MASUNAGA since 1905Wisteria 43 BR/PK Gold 492025-12-04
04582647307262MASUNAGA since 1905Wisteria 59 BK/BK 492025-12-04
04582647307279MASUNAGA since 1905CROSBY 19 BLACK/GOLD 512025-09-02
04582647306487MASUNAGA since 1905Chord C 102 K18+Titan 482025-09-02
04582647306494MASUNAGA since 1905Chord E 102 K18+Titan 482025-09-02
04582647306500MASUNAGA since 1905Yugiri 19 BK/GP 502025-09-02
04582647306517MASUNAGA since 1905Yugiri 23 BR/BK 502025-09-02
04582647306524MASUNAGA since 1905Yugiri 35 BLUE/GP 502025-09-02
04582647306531MASUNAGA since 1905Yugiri 19 SG-BK/GP 502025-09-02
04582647306548MASUNAGA since 1905Yugiri 35 SG-BLUE/GP 502025-09-02
04582647306555MASUNAGA since 1905Fuji 15 NAVY/GP 532025-09-02
04582647306562MASUNAGA since 1905Fuji 24 GRY/BK 532025-09-02
04582647306579MASUNAGA since 1905Nova 19 Black 522025-09-02
04582647306586MASUNAGA since 1905Nova 29 Black/Gry 522025-09-02
04582647306593MASUNAGA since 1905Nova 19 SG-Black 522025-09-02
04582647306609MASUNAGA since 1905Nova 29 SG-Black/Gry 522025-09-02

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