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510(k) Data Aggregation
K Number
K161275Device Name
EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
Manufacturer
RESEARCH INSTRUMENTS LIMITED
Date Cleared
2017-01-23
(262 days)
Product Code
MQH, CLA, MOH
Regulation Number
884.6130Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH INSTRUMENTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an occyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
Device Description
The EZ-Tip pipette is an extruded medical grade polycarbonate capillary that is pulled at one end to form a tapered tip. It has an outer diameter (OD) of 0.9 mm at the proximal end and fits to an actuating device such as the EZ-Grip. All tips are approximately 90 mm in length and depending on the size of the tip they have a volumetric capacity of 15.9 - 25.4 µl.
Pipette Tips are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:
- Size 75 µm, 200 µm, 250 µm, 290 µm, 600 µm are suitable for specimen handling
- Sizes 125 µm, 135 µm, 145 µm, 155 µm, 170 µm are suitable for denudation
The EZ-Tip is supplied sterile in one of two packaging options; individually blister packed or pouch packed in a vial containing 20 tips. All pipettes are intended single use and disposable.
The EZ-Grip is a hand held, reusable actuator or pipeter for plastic pipettes. It consists of a machined aluminium barrel containing stainless steel and PTFE internal working mechanisms, a titanium plunger wire and medical grade silicone and nylon seals. The plunger mechanism is designed to be compatible with 0.9 mm OD plastic pipettes and it has an aspiration volume range of 0.2 µl to 3 µl with a blow-out volume of 1.4 µl above the adjusted aspiration volume setting.
The EZ-Grip is supplied non-sterile with validated protocols for cleaning and sterilization included in the Instructions for Use.
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K Number
K160504Device Name
RI Witness Embryology Heated Plate
Manufacturer
RESEARCH INSTRUMENTS LIMITED
Date Cleared
2016-07-18
(145 days)
Product Code
MQG, MOG
Regulation Number
884.6120Why did this record match?
Applicant Name (Manufacturer) :
RESEARCH INSTRUMENTS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle.
Device Description
The RI Witness Embryology Heated Plate is designed to maintain the temperature of embryos and other reproductive tissues placed in dishes on the surface of the device. It is typically installed in a flow hood or on a work bench and comprises of a central clear window within a solid baseplate containing the temperature controller. There are 5 heating circuits, one for the window that uses ITO coated glass and the other 4 use power resistors screwed in thermal contact to the aluminium base plate.
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