FDA.reportPublic FDA data

BEVEL

Primary DI
G1318705HULB0
Brand
BEVEL
Company
Incite International Inc
Model
8705HULB
Device description
STELLA - HULB - Humid/Lavender Blue - 47 * 16 - 136
Published
2022-08-01
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
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810109933907PrimaryGS10
G1318705HULB0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810109933907008101099339078101099339070810109933907

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

Contacts#

Phone, Email table
PhoneEmail
000-000-0000gudid@bevelspecs.com

Regulatory Flags#

DUNS number
113911866
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
00810109935451BEVEL8740BCSB2022-11-01
00810109935468BEVEL8740BSGB2022-11-01
00810109935475BEVEL8740DIMI2022-11-01
00810109935482BEVEL8740GTMB2022-11-01
00810109935499BEVEL8740MASA2022-11-01
00810109935505BEVEL8740SLDI2022-11-01
00810109935512BEVEL8741AZPR2022-11-01
00810109935529BEVEL8741BBFG2022-11-01
00810109935536BEVEL8741BCDI2022-11-01
00810109935543BEVEL8741BUDB2022-11-01
00810109935550BEVEL8741GGWT2022-11-01
00810109935567BEVEL8741TGBM2022-11-01
00810109935574BEVEL8742BKLP2022-11-01
00810109935581BEVEL8742GTWR2022-11-01
00810109935598BEVEL8742GYPO2022-11-01
00810109935604BEVEL8742LEPP2022-11-01
00810109935611BEVEL8742RQSY2022-11-01
00810109935628BEVEL8742WREG2022-11-01
00810109935635BEVEL8743AYMI2022-11-01
00810109935642BEVEL8743AZPR2022-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348921041Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921058Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921096Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921102Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
03701629015006Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-21
08800348920501Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920518Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920587Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920594Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920600Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920617Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920662Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920679Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920716Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920723Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920730Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920778Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920785Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920860Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10