FDA.report

C-flex Hydrophilic Acrylic Injectable IOL

Primary DI
05029867802003
Brand
C-flex Hydrophilic Acrylic Injectable IOL
Company
RAYNER INTRAOCULAR LENSES LIMITED
Model
570C
Catalog number
570C/+8.0
Published
2015-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HQLIntraocular Lens

Product Code Classifications

CodeDeviceSpecialtyClass
HQLIntraocular LensOphthalmic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05029867802003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05029867802003050298678020035029867802003

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.
Storage Environment Temperature32 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+441273205401feedback@rayner.com

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
false
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

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05029867689550RayOne SphericRAO100CRAO100C/+17.52021-05-05

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