Kitazato OPU Needle Type2-V6
The Kitazato OPU Needle Type2-v6 is an aspiration needle used to obtain oocytes from ovarian follicles. It passes through the vaginal wall to reach the follicle and is supplied as an…
The Kitazato OPU Needle Type2-v6 is an aspiration needle used to obtain oocytes from ovarian follicles. It passes through the vaginal wall to reach the follicle and is supplied as an assembly with connection tubing and a silicone stopper connector.
Type2-v6 has a green needle hub and a 21 gauge needle with an outside diameter of 0.80 mm. These dimensions identify this Type 2 configuration within the OPU needle range.
Available Lengths
The Type2-v6 configuration is offered with needle lengths from 200 to 350 mm in 25 mm increments. Connection tubing is available in lengths of 200, 300, 400, 600, 800 or 1000 mm.
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 | 2023-08-07 (version 8) |
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 |
|---|---|---|
| 351304 Type2-v6 | 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.