FDA.reportPublic FDA data

C-flex Aspheric Hydrophilic Acrylic Injectable IOL

Primary DI
05029867803611
Brand
C-flex Aspheric Hydrophilic Acrylic Injectable IOL
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
970C
Catalog number
970C/+13.5
Published
2018-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HQLIntraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05029867803611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05029867803611050298678036115029867803611

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place
Storage Environment Temperature32 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441903258900feedback@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
05029867021596RayOne EMV ToricRAO210TW01-RAO210T/+10.5SE+3.752025-10-13
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

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Primary DI, Brand, Company table
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