Device Information

Indications

This G-Vitri Vitrification Freeze Media and G-Vitri Vitrification Thawing Media are indicated for vitrification (freezing) and thawing of human oocytes (eggs) during fertility treatments.

Intended Use

This media is intended for medical professionals to use in assisted reproductive technologies. It is designed for the safe vitrification and thawing of human oocytes, primarily during fertility treatments.

Availability

This device is available by prescription only.

Regulatory Information

The device is cleared as substantially equivalent to legally marketed predicate devices. The manufacturer must comply with FDA regulations, including quality system regulations (21 CFR Part 820) and postmarketing reporting requirements.

Manufacturer Information

• Name: Gimbo Medical Technology Shenzhen Co., Ltd.
• Address: 601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, 518107 China
• Contact Person: Leo Guo, General Manager

Predicate Device Information

• Predicate Device Name and 510(k) Number: Not specified

Implications

The availability of this device provides an important tool in assisted reproductive technologies, offering patients undergoing fertility treatments a solution for vitrifying and thawing oocytes.

References

1. G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media. 510k Number: K232942. FDA Summary Link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232942