Intrauterine Insemination Cannula
Intra uterine Artificial Insemination
5manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product 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 | Gynetics Medical Products NV, Belgium |
|---|---|
| FDA product code | MQF |
| Device type | Catheter, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6110 |
| Establishment | Manufacturer |
| 510(k) | K013501 |
| Record published | 2017-01-17 |
| Record revised | 2019-01-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| 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 |
| Packaging | Pack of 25, pack of 125, pack of 75 |
| Sizes | Length 206 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| #4502 B Seminor Flexible | In distribution | |
| #4225 Smooze Medium | In distribution | |
| #4225 Smooze Long | In distribution | |
| #4220 IUI | Length 206 mm | In distribution |
| #4220 IUI Memo | Length 206 mm | In distribution |
| #4502 A Seminor Rigid | In distribution | |
| #4220 Plus | In distribution | |
| #4225 Smooze | 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 |
| 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 |
|---|---|
| K013536 | 2001-11-30 |
| K013501 | 2001-11-30 |
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.