FDA.reportPublic FDA data

LEGION

Primary DI
00380657530892
Brand
LEGION
Company
Alcon Laboratories, Inc.
Model
8065753089
Device description
LEGION Cart
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HMFStand, Instrument, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380657530892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380657530892003806575308923806575308920380657530892

GMDN Terms#

Term, Definition table
TermDefinition
Medical device integration rackA device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
008018525
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00380657530021ORA SYSTEM, VerifEye80657530022026-07-22
00380657530274LEGION80657530272026-07-22
00380657530281LEGION80657530282026-07-22
00380657530298LEGION, INTREPID80657530292026-07-22
00380657530373LEGION80657530372026-07-22
00380657530502LEGION80657530502026-07-22
00380657530564LEGION80657530562026-07-22
00380657530755LEGION80657530752026-07-22
00380657531639LEGION, KELMAN80657531632026-07-22
00380657531646LEGION, KELMAN80657531642026-07-22
00380657531653LEGION, INTREPID, KELMAN80657531652026-07-22
00380657531660LEGION, INTREPID, KELMAN80657531662026-07-22
00380659983313ORA SYSTEM, VerifEye80659983312026-07-22
07612717071582FINESSE REFLEX806.432022-06-22
07612717071612FINESSE REFLEX806.442022-06-22
07612717071629FINESSE REFLEX806.452022-06-22
07612717071636FINESSE REFLEX806.472022-06-22
00380657410859Alcon, Infiniti, MicroSmooth, ABS80657410852016-09-24
00380657410873Alcon, Infiniti, MicroSmooth, Kelman, ABS80657410872016-09-24
00380657410972Alcon, Infiniti, MicroSmooth, ABS80657410972016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190015TOPCONANTONI CARLES SAHMF2026-06-01
00850020301638RelianceHAAG-STREIT USA, INC.HMF2026-05-29
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694596Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428616IS-5500TOPCON HEALTHCARE INCHMF2024-05-28
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17