Kitazato OPU Needle Type2-V2
The Kitazato OPU Needle Type2-v2 is used to obtain oocytes from ovarian follicles. It punctures through the vaginal wall to access the follicle and forms an aspiration assembly with…
The Kitazato OPU Needle Type2-v2 is used to obtain oocytes from ovarian follicles. It punctures through the vaginal wall to access the follicle and forms an aspiration assembly with connection tubing and a silicone stopper connector.
The Type2-v2 configuration has a light brown hub and a 17 gauge needle with a 1.49 mm outside diameter. It is one of the Type 2 OPU needle configurations.
Length Options
Needle lengths range from 200 to 350 mm in 25 mm increments. The corresponding connection tubing options are 200, 300, 400, 600, 800 and 1000 mm long.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Kitazato Corporation, Japan |
|---|---|
| FDA product code | MQE |
| Device type | Needle, Assisted Reproduction |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6100 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112462 |
| Record published | 2016-11-09 |
| Record revised | 2024-04-15 (version 9) |
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, serial number |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 357354 Type2-v2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | William A. Cook Australia PTY, Ltd. | 71 |
| Follicle Aspiration Set Single Lumen | Vitrolife Sweden AB | 40 |
| Follicle Aspiration Set, Double Lumen | Vitrolife Sweden AB | 28 |
| Wallace | ICU Medical, Inc | 20 |
| Kitazato OPU Needle with Connection Tube, Type2-v17 | Kitazato Corporation | 18 |
| Labotect | Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung | 16 |
| Kitazato OPU Needle | Kitazato Corporation | 12 |
| Follicle Aspiration Set Reduced Single Lumen | Vitrolife Sweden AB | 11 |
| Follicle Aspiration Set Single Lumen, Luer | Vitrolife Sweden AB | 9 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 8 |
| 17G Wallace Dual Lumen Oocyte Recovery Set | Coopersurgical, Inc. | 3 |
| ACE-M | Allwin Medical Devices, Inc. | 3 |
Showing 12 of 65. All products under Needle, Assisted Reproduction
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162881 | 2017-07-11 |
| K112462 | 2012-11-26 |
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.