FDA.reportPublic FDA data

Bertelli Collection

Primary DI
00676190385489
Brand
Bertelli Collection
Company
WestGroupe Optical Inc
Model
B-918 BLACK GOLD
Published
2020-06-29
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

Product Codes#

Code, Name table
CodeName
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00676190385489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00676190385489006761903854896761903854890676190385489

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
204096080
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00676190867831Superflex Sun CollectionSFS-2032 DUSTY ROSE TORTSFS2032S4095020C2026-03-02
00676190867879Superflex Sun CollectionSFS-2032 BLUE TORTSFS2032S4015020C2026-03-02
00676190867916Superflex Sun CollectionSFS-2032 BLACK IVORYSFS2032S3005020C2026-03-02
00676190867954Superflex Sun CollectionSFS-2033 ICESFS2033M3135916C2026-03-02
00676190867992Superflex Sun CollectionSFS-2033 MATTE BLACKSFS2033M3005916C2026-03-02
00676190875461One True Pair SunOTPS-2061 M.BLACK TORTOTPS2061M3005022C2026-03-02
00676190875508One True Pair SunOTPS-2061 TEAL AMBEROTPS2061S3045022C2026-03-02
00676190875546One True Pair SunOTPS-2061 TOKYO TORTOTPS2061S4125022C2026-03-02
00676190875584One True Pair SunOTPS-2065 BLACKOTPS2065S3005421C2026-03-02
00676190875621One True Pair SunOTPS-2065 DUSTY ROSEOTPS2065S3095421C2026-03-02
00676190875669One True Pair SunOTPS-2065 CREAMOTPS2065S3185421C2026-03-02
00676190869682Fysh SunwearF-2139 BLACK SNOW LEOPF2139S4005419C2026-01-19
00676190869729Fysh SunwearF-2139 NAVY MARBLEF2139S4015419C2026-01-19
00676190869767Fysh SunwearF-2139 MOCHA SMOKEF2139S4025419C2026-01-19
00676190869804Fysh SunwearF-2135 BLACK PEARLESCF2135S4005321C2026-01-19
00676190869842Fysh SunwearF-2135 NAVY BLOOMF2135S4015321C2026-01-19
00676190869880Fysh SunwearF-2135 FOREST BLOOMF2135S4165321C2026-01-19
00676190871265Fysh SunwearF-2138 AQUA PURPLEF2138S4045122C2026-01-19
00676190871302Fysh SunwearF-2138 BLACK RS MOSAICF2138S3005122C2026-01-19
00676190871340Fysh SunwearF-2138 MOCHA SHIMMERF2138S4025122C2026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332269944Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-05-22
00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905498Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905504Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
03701629014115Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
04066209005051FielmannFielmann Group AGHQZ2026-02-11
04066209005341FielmannFielmann Group AGHQZ2026-02-11
04066209005358FielmannFielmann Group AGHQZ2026-02-11
04066209005389FielmannFielmann Group AGHQZ2026-02-11
04066209006034FielmannFielmann Group AGHQZ2026-02-11
04066209006041FielmannFielmann Group AGHQZ2026-02-11
04066209006089FielmannFielmann Group AGHQZ2026-02-11
04066209008182FielmannFielmann Group AGHQZ2026-02-11
04066209008199FielmannFielmann Group AGHQZ2026-02-11
04066209008205FielmannFielmann Group AGHQZ2026-02-11
04066209008212FielmannFielmann Group AGHQZ2026-02-11
04066209008229FielmannFielmann Group AGHQZ2026-02-11
04066209008236FielmannFielmann Group AGHQZ2026-02-11
04066209009424FielmannFielmann Group AGHQZ2026-02-11
04066209019669FielmannFielmann Group AGHQZ2026-02-11
04066209019676FielmannFielmann Group AGHQZ2026-02-11
04066209019683FielmannFielmann Group AGHQZ2026-02-11
04066209019867FielmannFielmann Group AGHQZ2026-02-11