FDA.report

PANAMA JACK

Primary DI
00193033199282
Brand
PANAMA JACK
Company
FGX INTERNATIONAL INC.
Model
10251909.MCV
Published
2022-06-22
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

Contact Domains

Product Codes

CodeName
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00193033199282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00193033199282001930331992821930331992820193033199282

GMDN Terms

TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods

Method

Contacts

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 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

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