Transem Spherical
Transem Spherical is an embryo transfer catheter used to place embryos into the uterine cavity during infertility treatment. The TSET24SAS configuration has a spherical tip and a catheter…
Transem Spherical is an embryo transfer catheter used to place embryos into the uterine cavity during infertility treatment. The TSET24SAS configuration has a spherical tip and a catheter length of 24 cm.
The catheter provides a passage for embryo transfer through the cervix. Separate Transem stylets are available to assist catheter insertion when passage through the cervix is impeded.
Listed Item
Embryo transfer catheter, spherical tip.
Supply and Handling
The catheter is supplied in a blister pack, sterilized by irradiation, and intended for single use. Its packaged shelf life is 1.3 years.
Who Else Makes It
Concentrated in Guangdong (4), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| UKS Medical Technology (Chongqing) Co., Ltd. | Chongging | Sichuan | Contract manufacturer | 4 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| CGN Gray (Shenzhen) Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Guangzhou Hehong Biotech Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
Record
| Listed by | Origio A/S, Denmark |
|---|---|
| FDA product code | MQF |
| Device type | Catheter, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6110 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K161547 |
| Record published | 2017-07-16 |
| Record revised | 2019-01-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 0 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TSET24SAS | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kitazato ET Catheter | Kitazato Corporation | 53 |
| Soft-Pass | Cook Incorporated | 21 |
| kitazato IUI Catheter | Kitazato Corporation | 20 |
| Soft-Trans | Cook Incorporated | 20 |
| Guardia | Cook Incorporated | 15 |
| Wallace | ICU Medical, Inc | 12 |
| Intrauterine insemination cannula | Gynetics Medical Products NV | 8 |
| Catheter, Assisted Reproduction | C R I | 8 |
| Minvitro Embryo Transfer Catheter | Guangzhou Hehong Biotech Co., Ltd. | 6 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 5 |
| Labotect | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 5 |
| Microvol | Cook Incorporated | 5 |
Showing 12 of 111. All products under Catheter, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161547 | 2017-03-09 |
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.