FDA.reportPublic FDA data

RayOne Galaxy Toric

Primary DI
05029867025839
Brand
RayOne Galaxy Toric
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
RAO615X
Catalog number
W01-RAO615X/+8.5SE+3.75
Published
2026-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MFKLens, Multifocal Intraocular
MJPLens, Intraocular, Toric Optics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFKLens, Multifocal IntraocularOphthalmic3
MJPLens, Intraocular, Toric OpticsOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05029867025839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05029867025839050298670258395029867025839

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
217427954
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
05029867007026RayOne GalaxyRAO605GW01-RAO605G/+6.02026-09-29
05029867007033RayOne GalaxyRAO605GW01-RAO605G/+6.52026-09-29
05029867007040RayOne GalaxyRAO605GW01-RAO605G/+7.02026-09-29
05029867007057RayOne GalaxyRAO605GW01-RAO605G/+7.52026-09-29
05029867007064RayOne GalaxyRAO605GW01-RAO605G/+8.02026-09-29
05029867007071RayOne GalaxyRAO605GW01-RAO605G/+8.52026-09-29
05029867007088RayOne GalaxyRAO605GW01-RAO605G/+9.02026-09-29
05029867007095RayOne GalaxyRAO605GW01-RAO605G/+9.52026-09-29
05029867007101RayOne GalaxyRAO605GW01-RAO605G/+10.02026-09-29
05029867007118RayOne GalaxyRAO605GW01-RAO605G/+10.52026-09-29
05029867007125RayOne GalaxyRAO605GW01-RAO605G/+11.02026-09-29
05029867007132RayOne GalaxyRAO605GW01-RAO605G/+11.52026-09-29
05029867007149RayOne GalaxyRAO605GW01-RAO605G/+12.02026-09-29
05029867007156RayOne GalaxyRAO605GW01-RAO605G/+12.52026-09-29
05029867007163RayOne GalaxyRAO605GW01-RAO605G/+13.02026-09-29
05029867007170RayOne GalaxyRAO605GW01-RAO605G/+13.52026-09-29
05029867007187RayOne GalaxyRAO605GW01-RAO605G/+14.02026-09-29
05029867007194RayOne GalaxyRAO605GW01-RAO605G/+14.52026-09-29
05029867007200RayOne GalaxyRAO605GW01-RAO605G/+15.02026-09-29
05029867007217RayOne GalaxyRAO605GW01-RAO605G/+15.52026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05029867007026RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007033RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007040RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007057RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007064RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007071RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007088RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007095RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007101RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007118RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007125RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007132RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007149RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007156RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007163RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007170RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007187RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007194RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007200RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007217RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007224RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007231RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007248RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007255RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007262RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007279RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007286RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007293RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007309RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29
05029867007316RayOne GalaxyRAYNER INTRAOCULAR LENSES LIMITEDMFK2026-09-29