ASSORTED BRANDS

GUDID 00057800251965

FGX INTERNATIONAL INC.

Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles
Primary Device ID00057800251965
NIH Device Record Keyef9e5b2b-49c7-4417-bf5f-6b1ec24ed312
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSORTED BRANDS
Version Model NumberDL5836/48.SDM
Company DUNS062312087
Company NameFGX INTERNATIONAL INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com
Phone+1(401)231-3800
EmailCustomerservices@fgxi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100057800251965 [Primary]

FDA Product Code

HOISpectacle, magnifying

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-19
Device Publish Date2022-10-11

On-Brand Devices [ASSORTED BRANDS]

00887661970244ASTR833-200.FGX
00193033435434DL5575/212.BJS
00193033435410DL5573/108.MBJ
00193033435403DL5572/108.MBJ
00193033435397DL5571/480.MBJ
00193033435380DL5570/480.MBJ
00193033430620DL5496/112.FWG
00193033430026DL5478/222.VER
00193033430002DL5479/44.VER
00193033424216DL5472/240.DWU
00193033424186DL5469/192.FWM
00193033424179DL5468/192.FWM
00193033424162DL5467/192.FWM
00193033397091DL5401/222.VER
00193033397084DL5400/222.VER
00193033383438DL5390/222.VER
0019303337021610251675.FGX
0019303337020910251673.FGX
0019303337019310251672.FGX
0019303337018610251671.FGX
0019303337016210251674.FGX
0019303337015510251670.FGX
00193033366899DL5370/142.FDR
00193033331507ASTSR16.FGX
00193033322079ASTRD19-250.CSS
00193033322062ASTRD19-200.CSS
00193033322055ASTRD19-150.CSS
00193033322031DL5353/66.CGR
00193033322024DL5352/36.CGR
00193033322000DL5350/36.CGR
00193033321997DL5349/36.CGR
00193033187326ASTSN2038.LRI
00193033187319ASTSN2037.LRI
00193033121917DL5024/146.FWM
00193033121894DL5022/268.FWM
00193033121887DL5021/146.FWM
00193033068502DL4839/36.CGR
00193033068496DL4838/36.CGR
00193033068434DL4837/36.CGU
00887661635105DL4722/30.FTG
00887661635075DL4720/12.FTG
00887661635068DL4718/12.FTG
00887661635013DL4725/44.FTG
00887661634986DL4723/44.FTG
00887661634931ARD89-ST.LRI
00887661634900DL4717/8.FTG
00887661634719DL4714/24.FGX
00887661621733ASTSN1868.FGX
00887661613370DL4692/12.FTG
00887661607980DL4687/12.FTG

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