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510(k) Data Aggregation
K Number
K081455Device Name
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
Manufacturer
RAYNER SURGICAL INC
Date Cleared
2008-09-05
(105 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER SURGICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The single-use small incision disposable injector (model number R-INJ-06) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
Device Description
The single-use small incision disposable injector (model number R-INJ-06) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The small incision injector (model number R-INJ-06) is a plastic, single-use disposable device. The injector components barrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarbonate. The injector is transparent and the plunger is white.
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K Number
K062612Device Name
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
Manufacturer
RAYNER SURGICAL INC
Date Cleared
2006-12-13
(99 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER SURGICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
Device Description
The disposable single-use soft tipped injector (model number R-INJ-04) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. It is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery.
The soft tipped injector (model number R-INJ-04) is a plastic, single-use disposable device.
The injector components barrel, flap, nozzle and bush are made of polypropylene. The plunger is a polypropylene with a soft tip made from a Thermoplastic Elastomer (TPE). The injector is transparent and the plunger has a blue tip.
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K Number
K052651Device Name
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
Manufacturer
RAYNER SURGICAL INC
Date Cleared
2006-01-19
(115 days)
Product Code
MSS
Regulation Number
886.4300Why did this record match?
Applicant Name (Manufacturer) :
RAYNER SURGICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable single-use injector (model number R-INJ-02) is intended to be used to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling.
Device Description
The disposable single-use injector (model number R-INJ-02) is intended to compress and insert into the capsular bag only those IOL models that allow use of this injector in their approved labeling. The injector is designed to mechanically fold the lens and insert it into the eye during normal, small-incision cataract surgery. The disposable single-use injector is a plastic, single-use disposable device. The injector components barrel, flap, nozzle and bush are made of polypropylene, and the plunger is polycarbonate. The Spring is stainless steel. The injector is transparent and the plunger white in color.
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