FDA.reportPublic FDA data

AHLEM

Primary DI
03701558403332
Brand
AHLEM
Company
Ahlem Eyewear, LLC
Model
OM021-WHTG
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
03701558403332PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701558403332037015584033323701558403332

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
003946572
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701558414161AHLEMSM077-PEOG-NA/BLGR2024-07-25
03701558414178AHLEMSM077-GRYG-NA/GG152024-07-25
03701558414185AHLEMSM077-CHAM-NA/RAGR2024-07-25
03701558414192AHLEMSM076-RUBR-NA/ASHG2024-07-25
03701558414208AHLEMSM076-PEOG-NA/BLGR2024-07-25
03701558414215AHLEMSM076-GRYG-NA/GG152024-07-25
03701558414222AHLEMSM076-CHAM-NA/KHAL2024-07-25
03701558414604AHLEMOM077-PEOG-NA2024-07-25
03701558414611AHLEMOM077-GRYG-NA2024-07-25
03701558414628AHLEMOM077-CHAM-NA2024-07-25
03701558414826AHLEMOA094-SMKL2024-07-25
03701558414833AHLEMOA094-PETL2024-07-25
03701558414840AHLEMSA094-PEAC/KHAL2024-07-25
03701558414857AHLEMSA094-CLST/STOR2024-07-25
03701558414901AHLEMSA092-YLWT/KHAL2024-07-25
03701558414918AHLEMSA092-MLGN/RAGR2024-07-25
03701558414925AHLEMSA092-BLCK/STOR2024-07-25
03701558414932AHLEMSA091-STOL/GG152024-07-25
03701558414949AHLEMSA091-DRKL/ASHG2024-07-25
03701558414956AHLEMSA091-CLST/KHAL2024-07-25

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