Cryotec
Cryotec is a single-use device for vitrification procedures to contain and maintain human embryos at the 4 to 8 cell or blastocyst stage. The FDA filing describes it as a two-piece assembly…
Cryotec is a single-use device for vitrification procedures to contain and maintain human embryos at the 4 to 8 cell or blastocyst stage. The FDA filing describes it as a two-piece assembly with a film sheet attached to a handle and a cap.
During the procedure described in the filing, the film sheet is loaded with embryos, capped and immersed in liquid nitrogen. The cap covers the film during handling and storage. The device is supplied sterile and intended for single use.
Listed Item
Kitazato Cryotec (10 pieces) (Yellow)
Construction and Handling
The device description identifies PET for the film and handle and a weighted PVC cap. The filing describes the Cryotec as a single-use device supplied sterile.
Who Else Makes It
Concentrated in Guangdong (8), Hubei (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Boomingshing Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Wuhan Huchuang Union Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 8 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Reprolife Inc., Japan |
|---|---|
| FDA product code | MQK |
| Device type | Labware, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6160 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K162051 |
| Record published | 2017-08-31 |
| Record revised | 2023-10-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 20 °C; Handling environment temperature 10 to 20 °C |
| Distribution end date | 2017-08-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TEC004G | 4 | In distribution | |
| TEC010W | 10 | In distribution | |
| TEC004W | 4 | In distribution | |
| TEC004B | 4 | In distribution | |
| TEC004R | 4 | In distribution | |
| TEC004Y | 4 | In distribution | |
| TEC010B | 10 | In distribution | |
| TEC010R | 10 | In distribution | |
| TEC010Y | 10 | In distribution | |
| TEC010G | 10 | In distribution | |
| TEC110R | 10 | Withdrawn | |
| TEC110B | 10 | Withdrawn | |
| TEC110W | 10 | Withdrawn | |
| TEC110G | 10 | Withdrawn | |
| TEC110Y | 10 | Withdrawn | |
| TEC104B | 4 | Withdrawn | |
| TEC104G | 4 | Withdrawn | |
| TEC104R | 4 | Withdrawn | |
| TEC104W | 4 | Withdrawn | |
| TEC104Y | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VitriGuard | Origio A/S | 16 |
| G-Vitri™ Vitrification Straw | Gimbo Medical Technology Shenzhen Co., Ltd. | 15 |
| ZyMot | DxNow Inc. | 10 |
| LensHooke Sperm Separation Device | Bonraybio Co., Ltd. | 9 |
| cryo-GO Vitrification Device | Fujifilm Irvine Scientific | 9 |
| LifeGlobal® GPS® Dishware | Coopersurgical, Inc. | 7 |
| LifeGlobal® GPS® Dishware | LifeGlobal Group, LLC | 7 |
| Nest VT | Cook Incorporated | 5 |
| Surestrip | Allwin Medical Devices, Inc. | 5 |
| Minvitro Vitrification Straw | Guangzhou Hehong Biotech Co., Ltd. | 5 |
| Rapid-i Kit | Vitrolife Sweden AB | 5 |
| Surelock | Allwin Medical Devices, Inc. | 5 |
Showing 12 of 102. All products under Labware, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162051 | 2016-12-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.