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510(k) Data Aggregation
K Number
K143307Device Name
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
Manufacturer
Date Cleared
2014-12-18
(30 days)
Product Code
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER INTRAOCULAR LENSES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rayner Injectors (Models STW01 and RSP01) are intended to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.
Device Description
The Rayner Injectors are devices for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the Rayner Injectors in their approved labeling into the eye. The Rayner Injectors consist of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The Rayner Injectors are sterile, disposable plastic devices, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. Rayner Injectors are designed for single use only.
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K Number
K141091Device Name
RAYSERT PLUS INJECTOR
Manufacturer
Date Cleared
2014-05-28
(30 days)
Product Code
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER INTRAOCULAR LENSES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RaySert PLUS Small Incision Single Use Soft-Tipped Injector (Model R-INJ-10) is intended to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labeling.
Device Description
The RaySert PLUS Small Incision Single Use Soft-Tipped Injector is a device for folding and delivering Rayner C-flex intraocular lenses (models 570C and 970C), and other IOLs indicating the use of the RaySert PLUS in their approved labeling into the eye. The RaySert PLUS consists of a syringe shaped body and nozzle, with a soft tipped plunger, and a loading bay closed in use with a mobile flap. The RaySert PLUS is a sterile, disposable plastic device, with a narrow diameter circular lumen through which the IOL can be introduced into the eye in a single continuous action. RaySert PLUS is designed for single use only.
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K Number
K132002Device Name
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
Manufacturer
Date Cleared
2014-03-27
(269 days)
Product Code
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER INTRAOCULAR LENSES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The single use disposable injectors (Model R-INJ-04 and Model R-INJ-04/18) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling.
Device Description
There are two types of Rayner disposable single use soft tipped injectors (Model R-INJ-04 and Model R-INJ-04/18). They are the same except Model R-INJ-04 has a 2.0 mm diameter nozzle and Model R-INJ-04/18 has a 1.8 mm nozzle. The size is indicated on the barrel flap of the respective injectors by 1.8 or 2.0 embossed texts. The injectors are assembled from a nozzle, barrel, flap, guide bushes and plunger components which are made of polypropylene material. The plunger has a thermoplastic elastomer soft tip at one end. The injectors are supplied sterile.
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K Number
K091507Device Name
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
Manufacturer
Date Cleared
2009-12-04
(197 days)
Product Code
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER INTRAOCULAR LENSES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling.
Device Description
The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular bag only those intraocular Lenses that allow use of this injector in their approved labelling. It is designed to mechanically fold the lens and insert it into the eye during normal, small incision (1.8mm) cataract surgery. The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device. The injector components harrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarhonate. The injector is transparent and the plunger is white.
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