FDA.reportPublic FDA data

itek

Primary DI
00841133119876
Brand
itek
Company
NUVOMED, INC.
Model
SOG-4/1987
Device description
Smart Bluetooth Sport Sunglasses
Published
2022-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841133119876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841133119876008411331198768411331198760841133119876

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080809709
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859811007063NuvoMedBGTS50-24/07682018-09-04
00859811007681NuvoMed BGTS50-24/07682018-08-28
00859811009241NuvoMedTDT-6/09242020-10-30
00859811009234NuvoMedTBP-6/09232020-10-30
00859811009258NuvoMedTOS-6/09252020-10-30
00810110302099NuvoMedCTSS-12/02092024-03-22
00810110302105NuvoMedCTSL-12/02102024-03-22
00810110302112NuvoMedCTSX-12/02112024-03-22
00810110302129NuvoMedCTFP-6/02122024-03-22
00810110303492NuvoMedNWBP-6/03492024-10-18
00810110303508NuvoMedNABP-6/03502024-10-18
00810110303676NuvoMedLOS-12/03672024-12-13
00859811008947NuvoMedDCT-6/08942024-12-13
00859811007391NuvoMedFPO-6/07392018-09-10
00859811007261NuvoMedNGS50-24/07262019-01-29
00859811007414NuvomedMBG10-6/07412019-01-29
00810110302075NuvoMedBPMC-6/02072023-12-05
00859811007025NuvoMedNIET-6/07022018-06-15
00859811007018NuvoMedNBPM-6/07012018-06-15
00859811008510Bella RussoINV005642019-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332263010Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263041Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263584Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332263614Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264765Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264772Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264789Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332264796Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332269968Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
08800332269975Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-31
04582647307972MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307989MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307996MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308146MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308153MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308160MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308313MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308320MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308375MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308382MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308399MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308405MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308412MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308429MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308436MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308443MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308450MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308467MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308559MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308566MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30