FDA.report

Fielmann

Primary DI
04066209050310
Brand
Fielmann
Company
Fielmann Group AG
Model
LN 044 RN JACOB_27520
Published
2025-09-17
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
04066209050310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04066209050310040662090503104066209050310

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
312583602
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
04066209005051FielmannBD 311 MOD II CL_768332026-02-11
04066209005341FielmannBD 317 PILOT CL_205162026-02-11
04066209005358FielmannBD 317 PILOT CL_205172026-02-11
04066209005389FielmannBD 317 PILOT CL_9743802026-02-11
04066209006034FielmannBD 352 PANTO CL_234032026-02-11
04066209006041FielmannBD 352 PANTO CL_234142026-02-11
04066209006089FielmannBD 352 PANTO CL_746522026-02-11
04066209008182FielmannBD 455 CL_208212026-02-11
04066209008199FielmannBD 455 CL_208222026-02-11
04066209008205FielmannBD 455 CL_208232026-02-11
04066209008212FielmannBD 455 CL_208252026-02-11
04066209008229FielmannBD 455 CL_208262026-02-11
04066209008236FielmannBD 455 CL_208272026-02-11
04066209009424FielmannBD 507 CL_224462026-02-11
04066209019669FielmannMC 176 TR_795002026-02-11
04066209019676FielmannMC 176 TR_795102026-02-11
04066209019683FielmannMC 176 TR_795212026-02-11
04066209019867FielmannMC 176 TR_9080362026-02-11
04066209019980FielmannMC 176 TR_9081552026-02-11
04066209020429FielmannMC 232 FA_205522026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800332269944Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-05-22
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