FDA.reportPublic FDA data

BEVEL

Primary DI
G1318667DGIB0
Brand
BEVEL
Company
Incite International Inc
Model
8667DGIB
Device description
HAND OF GOD - DGIB - Dark Grey/Ice Blue - 54 * 18 - 141
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
00810109933167PrimaryGS10
G1318667DGIB0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810109933167008101099331678101099331670810109933167

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
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30