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The Minitube SC-2000 + 2045 temperature control unit is indicated maintaining the temperature of biological material like gametes and embryos at a certain temperature which is essential to rover multiple applications in reproductive medicine, biology and other areas.

The Minitube Temperature Control Unit SC-2000 & SC-2045 is a temperature control unit. The only distinguishing feature between the SC-2000 and the SC-2045 is that the inserts on the warming plates of the SC-2045 are at a 45 degree angle from a level horizontal plane, whereas the SC-2000 inserts are vertical to that plane.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Minitube Temperature Control Unit SC-2000 & SC-2045." This letter determines substantial equivalence to a predicate device but does not contain the acceptance criteria, study details, or performance data typically found in a clinical study report.

Therefore, I cannot extract the information required to answer your request. The document explicitly states:

"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device's approval is based on its similarity to an already approved device, rather than new clinical trials with specific acceptance criteria and performance studies for this particular device.

To provide the information you've requested, I would need a different type of document, such as a complete 510(k) submission, a clinical study report, or a summary of safety and effectiveness data.

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