Soft-Trans
Soft-Trans Embryo Transfer Catheter With Gold Tip
5manufacturers in China registered for this device type
20catalogue numbers in this listing
7510(k) clearances naming this product code
5recalls on this code
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | MQF |
| Device type | Catheter, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6110 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2019-09-02 (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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2019-09-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G49406 | In distribution | |
| G03362 | In distribution | |
| G20481 | Withdrawn | |
| G29639 | Withdrawn | |
| G20197 | Withdrawn | |
| G26151 | Withdrawn | |
| G26640 | Withdrawn | |
| G49408 | Withdrawn | |
| G26669 | Withdrawn | |
| G49407 | Withdrawn | |
| G20312 | Withdrawn | |
| G26179 | Withdrawn | |
| G29634 | Withdrawn | |
| G49409 | Withdrawn | |
| G26662 | Withdrawn | |
| G20370 | Withdrawn | |
| G26779 | Withdrawn | |
| G20195 | Withdrawn | |
| G32755 | Withdrawn | |
| G29635 | Withdrawn |
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 |
| 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 |
| Tefcat | Cook Incorporated | 4 |
Showing 12 of 111. All products under Catheter, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191015 | 2019-05-17 |
| K180302 | 2018-10-24 |
| K173103 | 2018-04-13 |
| K173686 | 2018-04-11 |
| K172051 | 2018-01-10 |
| K172321 | 2017-12-21 |
| K163318 | 2017-07-14 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-03 | Class II | Under Investigation by firm | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need | 202 | 2020-05-13 |
| 2019-10-03 | Class II | Under Investigation by firm | Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product is used include increased procedural time, the need | 400 | 2020-05-13 |
| 2017-12-19 | Class II | Process control | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. | 57 | 2019-04-09 |
| 2017-12-19 | Class II | Process control | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. | 21 | 2019-04-09 |
| 2017-12-19 | Class II | Process control | Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and/or nonviable embryos. | 473 | 2019-04-09 |
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.