FDA.reportPublic FDA data

BEVEL

Primary DI
G1313730CTG0
Brand
BEVEL
Company
Incite International Inc
Model
3730CTG
Device description
NADINE - CTG - Cinder Tortoise Gradient - 54 * 17 - 135
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
00810109930265PrimaryGS10
G1313730CTG0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810109930265008101099302658101099302650810109930265

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
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
04580822704288EYEVANEYEVAN INC.HQZ2026-07-10
04580822704295EYEVANEYEVAN INC.HQZ2026-07-10
04580822704561EYEVANEYEVAN INC.HQZ2026-07-10
04580822704578EYEVANEYEVAN INC.HQZ2026-07-10
04580822704585EYEVANEYEVAN INC.HQZ2026-07-10
04580822704592EYEVANEYEVAN INC.HQZ2026-07-10
04580822704837EYEVANEYEVAN INC.HQZ2026-07-10
04580822704844EYEVANEYEVAN INC.HQZ2026-07-10
04580822704851EYEVANEYEVAN INC.HQZ2026-07-10
04580822704868EYEVANEYEVAN INC.HQZ2026-07-10
04580822704998EYEVANEYEVAN INC.HQZ2026-07-10
04580822705018EYEVANEYEVAN INC.HQZ2026-07-10
04580822705025EYEVANEYEVAN INC.HQZ2026-07-10
04580822705049EYEVANEYEVAN INC.HQZ2026-07-10
04582669065393EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065409EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065416EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065454EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065461EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065478EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065522EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065539EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065546EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065553EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10