FDA.reportPublic FDA data

C-flex Aspheric Hydrophilic Acrylic Injectable IOL

Primary DI
05029867803642
Brand
C-flex Aspheric Hydrophilic Acrylic Injectable IOL
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
970C
Catalog number
970C/+15.0
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
05029867803642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05029867803642050298678036425029867803642

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
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
00380658439668ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439675ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439682ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439699ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439705ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439712ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439729ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439736ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439743ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439750ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439767ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439774ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439781ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439798ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439804ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439811ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439828ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439835ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439842ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439859ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439866ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439873ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439880ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439897ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439903ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439910ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439927ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439934ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439941ClareonAlcon Laboratories, Inc.HQL2026-08-27
00380658439958ClareonAlcon Laboratories, Inc.HQL2026-08-27