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510(k) Data Aggregation
K Number
K022959Device Name
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
Manufacturer
MDC RESEARCH LTD.
Date Cleared
2003-02-05
(152 days)
Product Code
EJI
Regulation Number
872.6770Why did this record match?
Applicant Name (Manufacturer) :
MDC RESEARCH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.
Device Description
The SafeStep™ Safety Dental Cartridge Syringe consists of a single-use, disposable aspirating syringe-type injector with a separate re-usable plunger assembly indicated for the use in delivering dental anesthetics. The SafeStep™ Safety Dental Cartridge Syringe incorporates a needle safety mechanism that can be activated with one hand.
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K Number
K973012Device Name
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
Manufacturer
MDC RESEARCH LTD.
Date Cleared
1997-11-05
(84 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
MDC RESEARCH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A properly placed MDC Safe Step Safety Blood Collection Needle System incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to access a vein to obtain blood samples.
Device Description
The Safe Step Safety Blood Collection Needle System consists of four separate components: a blood collection needle assembly; an evacuated tube adapter; a front protective cap; and a rear protective cap.
The Safe Step Safery Blood Collection Needle System is a standard Blood Collection Needle System with the additional feature of a retractable needle. The needle safety mechanism can be activated by lifting the thumb pad (located on the rear piece of the tube adapter) upwards and forward, relative to the two finger tabs on the tube adapter front piece, after removing the last blood sample tube.
After needle retraction, the device is disposed of according to routine procedure in a sharps container.
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K Number
K960013Device Name
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
Manufacturer
MDC RESEARCH LTD.
Date Cleared
1996-02-13
(42 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
MDC RESEARCH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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