FDA.reportPublic FDA data

RayOne EMV Toric

Primary DI
05029867021596
Brand
RayOne EMV Toric
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
RAO210T
Catalog number
W01-RAO210T/+10.5SE+3.75
Published
2025-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens
MJPLens, Intraocular, Toric Optics

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3
MJPLens, Intraocular, Toric OpticsOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05029867021596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05029867021596050298670215965029867021596

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 Temperature41 Degrees Fahrenheit95 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+4401903258900feedback@rayner.com

Regulatory Flags#

DUNS number
217427954
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05029867021527RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+2.252025-10-13
05029867021534RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+3.002025-10-13
05029867021541RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+3.752025-10-13
05029867021558RayOne EMV ToricRAO210TW01-RAO210T/+10.0SE+4.502025-10-13
05029867021565RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+1.502025-10-13
05029867021589RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+3.002025-10-13
05029867021602RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+4.502025-10-13
05029867021619RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+1.502025-10-13
05029867021626RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+2.252025-10-13
05029867021640RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+3.752025-10-13
05029867021657RayOne EMV ToricRAO210TW01-RAO210T/+11.0SE+4.502025-10-13
05029867021664RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+1.502025-10-13
05029867021671RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+2.252025-10-13
05029867021688RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+3.002025-10-13
05029867021701RayOne EMV ToricRAO210TW01-RAO210T/+11.5SE+4.502025-10-13
05029867021718RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+1.502025-10-13
05029867021725RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+2.252025-10-13
05029867021732RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+3.002025-10-13
05029867021749RayOne EMV ToricRAO210TW01-RAO210T/+12.0SE+3.752025-10-13
05029867021763RayOne EMV ToricRAO210TW01-RAO210T/+12.5SE+1.502025-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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