FDA.reportPublic FDA data

BEVEL

Primary DI
G1318680TGBM0
Brand
BEVEL
Company
Incite International Inc
Model
8680TGBM
Device description
DOWNTON ABBEYNORMAL - TGBM - Tech Green/Blue Marine - 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
00810109933501PrimaryGS10
G1318680TGBM0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810109933501008101099335018101099335010810109933501

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
04582647307729MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307736MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307743MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307750MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307767MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307774MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307781MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307798MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307804MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307811MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307828MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307835MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307842MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307859MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307866MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307873MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307880MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307897MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307903MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307910MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307927MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307934MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307941MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307958MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307965MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308009MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308016MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308023MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308030MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308047MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30