FDA.report

AHLEM

Primary DI
03701558403448
Brand
AHLEM
Company
Ahlem Eyewear, LLC
Model
OM019-RGBR
Published
2022-12-01
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

Related Records

Product Codes

CodeName
HQZFrame, Spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701558403448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701558403448037015584034483701558403448

GMDN Terms

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

Regulatory Flags

DUNS number
003946572
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 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 DIBrandCompanyProduct codePublished
00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905498Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905504Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
03701629014115Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
04066209005051FielmannFielmann Group AGHQZ2026-02-11
04066209005341FielmannFielmann Group AGHQZ2026-02-11
04066209005358FielmannFielmann Group AGHQZ2026-02-11
04066209005389FielmannFielmann Group AGHQZ2026-02-11
04066209006034FielmannFielmann Group AGHQZ2026-02-11
04066209006041FielmannFielmann Group AGHQZ2026-02-11
04066209006089FielmannFielmann Group AGHQZ2026-02-11
04066209008182FielmannFielmann Group AGHQZ2026-02-11
04066209008199FielmannFielmann Group AGHQZ2026-02-11
04066209008205FielmannFielmann Group AGHQZ2026-02-11
04066209008212FielmannFielmann Group AGHQZ2026-02-11
04066209008229FielmannFielmann Group AGHQZ2026-02-11
04066209008236FielmannFielmann Group AGHQZ2026-02-11
04066209009424FielmannFielmann Group AGHQZ2026-02-11
04066209019669FielmannFielmann Group AGHQZ2026-02-11
04066209019676FielmannFielmann Group AGHQZ2026-02-11
04066209019683FielmannFielmann Group AGHQZ2026-02-11
04066209019867FielmannFielmann Group AGHQZ2026-02-11
04066209019980FielmannFielmann Group AGHQZ2026-02-11