FDA.reportPublic FDA data

DISNEY

Primary DI
00193033408728
Brand
DISNEY
Company
FGX INTERNATIONAL INC.
Model
5012433-125.COM
Published
2022-01-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOISpectacle, magnifying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193033408728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193033408728001930334087281930334087280193033408728

GMDN Terms#

Term, Definition table
TermDefinition
Prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(401)231-3800Customerservices@fgxi.com

Regulatory Flags#

DUNS number
062312087
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
00031568239199SOLAR SHIELD10501844.CGR2022-10-11
00031568323775ACCESSORY ESSENTIALS10402921.CGU2022-10-11
00031568513114UNBRANDED5014216-250.CGU2022-10-11
00031568629952FOSTER GRANT5014175-150.CGU2022-10-11
00031568629969FOSTER GRANT5014175-200.CGU2022-10-11
00031568629976FOSTER GRANT5014175-250.CGU2022-10-11
00031568657436UNBRANDED5014216-125.CGU2022-10-11
00031568657443UNBRANDED5014216-150.CGU2022-10-11
00031568657467UNBRANDED5014216-200.CGU2022-10-11
00031568657535UNBRANDED5014216-275.CGU2022-10-11
00031568715846FOSTER GRANT5014175-275.CGU2022-10-11
00057800251965ASSORTED BRANDSDL5836/48.SDM2022-10-11
00057800255475QUO10265185.SDM2022-10-11
00057800255482QUO10265183.SDM2022-10-11
00057800255499QUO10265181.SDM2022-10-11
00057800255505QUO10265182.SDM2022-10-11
00057800255512QUO10265186.SDM2022-10-11
00057800255529QUO10265184.SDM2022-10-11
00070135435268SOLAR SHIELD10501821.CGR2022-10-11
00192304008544READERS.COM5013635-500.COM2022-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770410873Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770415496Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00757770425211Bausch + LombBausch & Lomb IncorporatedHOI2025-08-18
00681131104302EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104333EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104340EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104357EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104364EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104371EquateWAL-MART STORES, INC.HOI2025-03-07
00681131104388EquateWAL-MART STORES, INC.HOI2025-03-07
00802807320752NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320776MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320769MAX STUDIOEvolutioneyes, Inc.HOI2024-07-03
00802807320745NICOLE MILLEREvolutioneyes, Inc.HOI2024-07-03
00802807320714NICOLE MILLEREvolutioneyes, Inc.HOI2024-06-26
00802807320653MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320660MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320677MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320738M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320691MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320707MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807320684MAX STUDIOEvolutioneyes, Inc.HOI2024-06-26
00802807357499ESPECEvolutioneyes, Inc.HOI2024-06-26
00802807320486EVOLUTIONEYESEvolutioneyes, Inc.HOI2024-05-14
00802807320578MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320530M BY MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14
00802807320493MAX EDITIONEvolutioneyes, Inc.HOI2024-05-14
00802807320554NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320646NICOLE MILLEREvolutioneyes, Inc.HOI2024-05-14
00802807320592MAX STUDIOEvolutioneyes, Inc.HOI2024-05-14